INDIANAPOLIS, May 19, 2021 /PRNewswire/ -- New data from across
Eli Lilly and Company's (NYSE: LLY) oncology portfolio will be
presented at the 2021 American Society of Clinical Oncology (ASCO)
Annual Meeting, held June 4-8, 2021.
The data include new analyses of Verzenio®
(abemaciclib) from the Phase 3 monarchE trial in patients
with hormone receptor-positive (HR+), human epidermal growth factor
receptor 2-negative (HER2-) early breast cancer (EBC) with a high
risk of recurrence who received neoadjuvant chemotherapy. In
addition, the first clinical data from the Phase 1 study of Lilly's
oral selective estrogen receptor degrader (SERD) will be presented
at the meeting.
Breast Cancer
Highlights
Verzenio® (abemaciclib)
Lilly will present a subgroup analysis from the positive Phase 3
monarchE trial in high-risk early breast cancer detailing the
invasive disease-free survival, distant relapse-free survival, and
safety outcomes in patients who received neoadjuvant chemotherapy,
as well as an analysis of a subgroup of patients from China. In addition, Lilly is publishing new
pre-clinical data which examine unique attributes of Verzenio among
CDK4 & 6 inhibitors. Lilly will also present an analysis of
real world evidence on the risk of recurrence in early breast
cancer.
Oral SERD
Loxo Oncology at Lilly will present an analysis of interim clinical
data from the ongoing, first-in-human, Phase 1a trial of LY3484356
in patients with estrogen receptor positive advanced breast cancer
and endometrial endometrioid cancer. The submitted abstract
utilized a November 2020 data cut-off
date, and the poster presentation will utilize an April 2021 data cut-off date.
Lung and Thyroid Cancer Highlights
Retevmo® (selpercatinib)
Lilly will present new data on Retevmo, including preliminary
results from the Phase 1/2 LIBRETTO-121 trial in pediatric patients
with advanced RET-altered solid tumors, as well as further
efficacy and safety updates from the Phase 1/2 LIBRETTO-001 study
of Retevmo in patients with metastatic RET fusion-positive
non-small cell lung cancer (NSCLC) and advanced or metastatic
RET-altered thyroid cancer.
In addition, analyses of racial disparities in biomarker testing
– including next-generation sequencing – and clinical trial
enrollment among patients with NSCLC will be presented at the
meeting.
Gastrointestinal Cancer Highlights
CYRAMZA® (ramucirumab) and
ERBITUX® (cetuximab)
Lilly will present data on prognostic and predictive factors in
patients with advanced hepatocellular carcinoma and elevated
alpha-fetoprotein treated with CYRAMZA, along with real world
evidence on ERBITUX in patients with metastatic colorectal
cancer.
A list of the oral and poster presentations, along with their
viewing details, as well as published abstracts are shared
below.
Breast
Cancer
|
Medicine
|
Abstract Title
and Lead Author
|
Presentation
Details
|
Verzenio
(abemaciclib)
|
Abemaciclib combined
with adjuvant
endocrine therapy in patients with
high risk early breast cancer who
received neoadjuvant chemotherapy;
Miguel Martin
|
Abstract
517
Session: Breast
Cancer—
Local/Regional/Adjuvant
Poster
Discussion
Friday, June 4, at
9:00-10:00 a.m.
EDT
|
Verzenio
(abemaciclib)
|
Efficacy and safety
analysis of
Chinese patients in monarchE:
abemaciclib combined with adjuvant
endocrine therapy for high risk HR+,
HER2- early breast cancer; Shao Zhimin
|
Abstract
522
Session: Breast
Cancer—
Local/Regional/Adjuvant
Poster
Available on demand
starting
Friday, June 4 at 9:00 a.m. EDT
|
Verzenio
(abemaciclib)
|
Characterizing
demographics, clinical,
and genomic characteristics for US
patients with HR+, HER2- metastatic
breast cancer following progression
on a CDK4 and 6 inhibitor; Fabrice Andre
|
Abstract
1015
Session: Breast
Cancer—
Metastatic
Poster
Discussion
Friday, June 4, at
9:00-10:00 a.m. EDT
|
Verzenio
(abemaciclib)
|
eMonarcHER: A phase 3
study of
abemaciclib plus standard adjuvant
endocrine therapy in patients with
HR+, HER2+, node-positive, high
risk early breast cancer; Sara M.
Tolaney
|
Abstract
TPS596
Session: Breast
Cancer—
Local/Regional/Adjuvant
Poster
Available on demand
starting
Friday, June 4 at 9:00 a.m. EDT
|
Verzenio
(abemaciclib)
|
A phase Ib study of
xentuzumab
plus abemaciclib and fulvestrant
in patients (pts) with advanced
hormone receptor-positive (HR+),
HER2-negative breast cancer (BC)
with visceral or non-visceral disease;
Douglas Yee
|
Abstract
1057
Session: Breast
Cancer—
Metastatic
Poster
Available on demand
starting
Friday, June 4 at 9:00 a.m. EDT
|
Verzenio
(abemaciclib)
|
Recurrence risk in
early breast
cancer as defined by clinicopathologic
features; Kristin M. Sheffield
|
Abstract
e18581
Publication only:
Health
Services Research and
Quality Improvement
|
Verzenio
(abemaciclib)
|
Abemaciclib, a CDK4
& 6 inhibitor
with unique pharmacological
properties for breast cancer
therapy; Torres Raquel
|
Abstract
e12506
Publication only:
Breast
Cancer—Local/Regional/Adjuvant
|
LY3484356
(oral SERD)
|
A first-in-human
phase 1a/b trial
of LY3484356, an oral selective
estrogen receptor (ER) degrader
(SERD) in ER+ advanced breast
cancer (aBC) and endometrial
endometrioid cancer (EEC):
Results from the EMBER study;
Komal Jhaveri
|
Abstract
1050
Session: Breast
Cancer—
Metastatic
Poster
Available on demand
starting
Friday, June 4 at 9:00 a.m. EDT
|
Lung and Thyroid
Cancers
|
Medicine
|
Abstract Title
and Lead Author
|
Presentation
Details
|
Retevmo
(selpercatinib)
|
Oral Selpercatinib in
Pediatric
Patients (pts) with Advanced
RET-Altered Solid or Primary
CNS Tumors: Preliminary Results
from the Phase 1/2 LIBRETTO-121
Trial; Daniel Morgenstern
|
Abstract
10009
Session: Pediatric
Oncology II
Oral
presentation
Friday, June 4, at
9:00 a.m. EDT
|
Retevmo
(selpercatinib)
|
Updated Overall
Efficacy and
Safety of Selpercatinib in Patients
(pts) with RET Fusion+ Non-Small-
Cell Lung Cancer (NSCLC); Benjamin
Besse
|
Abstract
9065
Session: Lung
Cancer—Non-
Small Cell Metastatic
Poster
Available on demand
starting
Friday, June 4 at 9:00 a.m. EDT
|
Retevmo
(selpercatinib)
|
Selpercatinib
efficacy and safety
in patients with RET-altered thyroid
cancer: a clinical trial update; Eric
Sherman
|
Abstract
6073
Session: Head and
Neck Cancer
Poster
Available on demand
starting
Friday, June 4 at 9:00 a.m. EDT
|
Retevmo
(selpercatinib)
|
Efficacy of
Selpercatinib After Prior
Systemic Therapy in Patients with
RET Mutant Medullary Thyroid
Cancer; Lori J. Wirth
|
Abstract
6074
Session: Head and
Neck Cancer
Poster
Available on demand
starting
Friday, June 4 at 9:00 a.m. EDT
|
Retevmo
(selpercatinib)
|
Response to
Selpercatinib Versus
Prior Systemic Therapy in Patients
(Pts) with RET Fusion+ Non-Small-
Cell Lung Cancer (NSCLC); Alexander
E. Drillon
|
Abstract
9032
Session: Lung
Cancer—Non-
Small Cell Metastatic
Available on demand
starting
Friday, June 4 at 9:00 a.m. EDT
|
N/A
|
Racial Disparities in
Biomarker Testing
and Clinical Trial Enrollment in Non-
Small Cell Lung Cancer (NSCLC);
Debora S. Bruno
|
Abstract
9005
Session: Lung
Cancer—Non-
Small Cell Metastatic
Oral
presentation
Friday, June 4, at
1:00 p.m. EDT
|
N/A
|
Challenges in Lung
Cancer
Multidisciplinary Collaboration
Experienced by Specialists in Four
Countries; Monaliben Patel MD
|
Abstract
e23002
Publication only:
Professional
Development and Education Advances
|
Gastrointestinal
Cancers
|
Medicine
|
Abstract Title
and Lead Author
|
Presentation
Details
|
CYRAMZA
(ramucirumab)
|
Prognostic and
predictive factors in
patients treated with ramucirumab
(RAM) with advanced hepatocellular
carcinoma (aHCC) and elevated alpha-
fetoprotein (AFP): results from two
Phase III trials; Joseph M. Llovet
|
Abstract
4146
Session:
Gastrointestinal Cancer—
Gastroesophageal, Pancreatic,
and Hepatobiliary
Poster
Available on demand
starting
Friday, June 4 at 9:00 a.m. EDT
|
ERBITUX
(cetuximab)
|
Real-World Time on
Treatment and
Overall Survival in Patients with
Metastatic Colorectal cancer receiving
Cetuximab in Second Line after failing
Irinotecan or Oxaliplatin-based Regimens;
Wambul Gathirua-Mwangi
|
Abstract
e15568
Publication only:
Gastrointestinal
Cancer – Colorectal and Anal
|
ERBITUX
(cetuximab)
|
A Retrospective
Analysis of Real-World
Time on Treatment and Overall Survival
in Patients with Metastatic Colorectal
Cancer receiving Cetuximab in Third Line;
Wambui Gathirua-Mwangi
|
Abstract
e15575
Publication
only:
Gastrointestinal
Cancer –
Colorectal and Anal
|
Prostate
Cancer
|
Medicine
|
Abstract Title
and Lead Author
|
Presentation
Details
|
Verzenio
(abemaciclib)
|
CYCLONE 1: A Phase 2
study of
abemaciclib in patients with metastatic
castration-resistant prostate cancer
(mCRPC) previously treated with a
novel hormonal agent and taxane-based
chemotherapy; Neeraj Agarwal
|
Abstract
TPS5086
Session:
Genitourinary Cancer—
Prostate, Testicular, and Penile
Poster
Available on demand
starting
Friday, June 4 at 9:00 a.m. EDT
|
Other
|
Medicine
|
Abstract Title
and Lead Author
|
Presentation
Details
|
olaratumab
|
Phase (Ph) 1b/2
evaluation of
olaratumab in combination with
gemcitabine and docetaxel in
advanced soft tissue sarcoma (STS);
Steven Attia
|
Abstract
11517
Session:
Sarcoma
Poster
Discussion
Friday, June 4, at
9:00 a.m. –
11:00 a.m. EDT
|
N/A
|
Racial distribution
of clinical trial
participants in the United States;
Monaliben Patel
|
Abstract
e18516
Publication only:
Health Services
Research and Quality Improvement
|
Notes to Editors
About Verzenio® (abemaciclib)
Verzenio (abemaciclib) is an inhibitor of cyclin-dependent kinases
(CDK)4 & 6, which are activated by binding to D-cyclins. In
estrogen receptor-positive (ER+) breast cancer cell lines, cyclin
D1 and CDK4 & 6 promote phosphorylation of the retinoblastoma
protein (Rb), cell cycle progression, and cell proliferation.
In vitro, continuous exposure to Verzenio inhibited Rb
phosphorylation and blocked progression from G1 to S phase of the
cell cycle, resulting in senescence and apoptosis (cell death).
Preclinically, Verzenio dosed daily without interruption resulted
in reduction of tumor size. Inhibiting CDK4 & 6 in healthy
cells can result in side effects, some of which may be serious.
Clinical evidence also suggests that Verzenio crosses the
blood-brain barrier. In patients with advanced cancer, including
breast cancer, concentrations of Verzenio and its active
metabolites (M2 and M20) in cerebrospinal fluid are comparable to
unbound plasma concentrations.
Verzenio is Lilly's first solid oral dosage form to be made
using a faster, more efficient process known as continuous
manufacturing. Continuous manufacturing is a new and advanced type
of manufacturing within the pharmaceutical industry, and Lilly is
one of the first companies to use this technology.
INDICATION FOR VERZENIO
Verzenio is indicated for the treatment of HR+, HER2- advanced or
metastatic breast cancer:
- in combination with an aromatase inhibitor for postmenopausal
women as initial endocrine-based therapy
- in combination with fulvestrant for women with disease
progression following endocrine therapy
- as a single agent for adult patients with disease progression
following endocrine therapy and prior chemotherapy in the
metastatic setting
About LY3484356
LY3484356 is an investigational, oral selective estrogen receptor
degrader (SERD) with pure antagonistic properties. The estrogen
receptor (ER) is the key therapeutic target for patients with
ER+/HER2- breast cancer. Novel degraders of ER may overcome
endocrine therapy resistance while providing consistent oral
pharmacology and convenience of administration. LY3484356 was
specifically designed to deliver continuous estrogen receptor
target inhibition throughout the dosing period and regardless of
ESR1 mutational status.
LY3484356 is currently being studied in the first-in-human,
multi-center Phase 1a/1b EMBER trial
in patients with estrogen receptor positive locally advanced or
metastatic breast cancer and other select non-breast cancers and in
the Phase 1 EMBER-2 trial in preoperative, postmenopausal women
with stage I-III, ER+/HER2- breast cancer. For additional
information about LY3484356 clinical trials, please refer to
www.clinicaltrials.gov. Interested patients and physicians can
contact the Loxo Oncology at Lilly clinical trial team by e-mailing
clinicaltrials@loxooncology.com.
About Retevmo® (selpercatinib)
Retevmo (selpercatinib, capsules 40mg, 80mg; formerly known as
LOXO-292) (pronounced reh-TEHV-moh) is a selective and potent RET
kinase inhibitor. Retevmo may affect both tumor cells and healthy
cells, which can result in side effects. RET-driver
alterations are predominantly mutually exclusive from other
oncogenic drivers. Retevmo is an U.S. FDA-approved oral
prescription medicine, 120 mg or 160 mg dependent on weight (<50
kg or ≥50 kg, respectively), taken twice daily until disease
progression or unacceptable toxicity.1 Continued
approval may be contingent upon verification and description of
clinical benefit in confirmatory trials.
INDICATIONS FOR RETEVMO
Retevmo is indicated for the treatment of adult patients with
metastatic rearranged during transfection fusion-positive non-small
cell lung cancer (NSCLC), and the treatment of adult and pediatric
patients 12 years of age and older with advanced or metastatic
RET-mutant medullary thyroid cancer (MTC) who require
systemic therapy, or advanced or metastatic RET
fusion-positive thyroid cancer who require systemic therapy and who
are radioactive iodine-refractory (if radioactive iodine is
appropriate). Retevmo was approved under the FDA's Accelerated
Approval regulations based on the LIBRETTO-001 Phase 1/2 trial's
endpoints of objective response rate (ORR) and duration of response
(DoR).
About CYRAMZA® (ramucirumab)
In the U.S., CYRAMZA (ramucirumab) has six FDA approvals to treat
four different types of cancers. CYRAMZA is being investigated in a
broad global development program that has enrolled more than 15,000
patients across more than 100 trials worldwide. These include
several studies investigating CYRAMZA in combination with other
anti-cancer therapies for the treatment of multiple tumor types. To
date, more than 150,000 patients have been treated with
CYRAMZA.
CYRAMZA is an antiangiogenic therapy. It is a vascular
endothelial growth factor (VEGF) Receptor 2 antagonist that binds
specifically to VEGFR-2, thereby blocking the binding of the
receptor ligands (VEGF-A, VEGF-C, and VEGF-D) – which may slow
tumor growth. CYRAMZA inhibited angiogenesis in an in vivo animal
model.
U.S. INDICATIONS FOR CYRAMZA
Gastric Cancer
CYRAMZA, as a single agent, or in combination with paclitaxel, is
indicated for the treatment of patients with advanced or metastatic
gastric or gastroesophageal junction (GEJ) adenocarcinoma with
disease progression on or after prior fluoropyrimidine- or
platinum-containing chemotherapy.
Non-Small Cell Lung Cancer
CYRAMZA, in combination with erlotinib, for first-line treatment of
metastatic non-small cell lung cancer with epidermal growth factor
receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
CYRAMZA, in combination with docetaxel, is indicated for the
treatment of patients with metastatic non-small cell lung cancer
(NSCLC) with disease progression on or after platinum-based
chemotherapy. Patients with epidermal growth factor receptor (EGFR)
or anaplastic lymphoma kinase (ALK) genomic tumor aberrations
should have disease progression on FDA-approved therapy for these
aberrations prior to receiving CYRAMZA.
Colorectal Cancer
CYRAMZA, in combination with FOLFIRI (irinotecan, folinic acid, and
fluorouracil), is indicated for the treatment of patients with
metastatic colorectal cancer (mCRC) with disease progression on or
after prior therapy with bevacizumab, oxaliplatin, and a
fluoropyrimidine.
Hepatocellular Carcinoma
CYRAMZA, as a single agent,
is indicated for the treatment of patients with hepatocellular
carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL
and have been treated with sorafenib.
About ERBITUX® (cetuximab)
Indications and Usage for ERBITUX (cetuximab) injection
Head and Neck Cancer
ERBITUX (cetuximab) is approved:
- ERBITUX, in combination with radiation therapy (RT), is
indicated for the initial treatment of locally or regionally
advanced squamous cell carcinoma of the head and neck (SCCHN)
- ERBITUX is indicated in combination with platinum-based therapy
and fluorouracil (CT) for the first-line treatment of patients with
recurrent locoregional disease or metastatic SCCHN
- ERBITUX, as a single agent, is indicated for the treatment of
patients with recurrent or metastatic SCCHN for whom prior
platinum-based therapy has failed
Metastatic Colorectal Cancer
ERBITUX is indicated for the treatment of KRAS wild-type,
epidermal growth factor receptor (EGFR)-expressing, metastatic
colorectal cancer (mCRC) as determined by an FDA-approved test for
this use:
- In combination with FOLFIRI (irinotecan, fluorouracil,
leucovorin) for first-line treatment
- In combination with irinotecan in patients who are refractory
to irinotecan-based chemotherapy
- As a single agent in patients who have failed oxaliplatin- and
irinotecan-based chemotherapy or who are intolerant to
irinotecan
Limitations of Use: ERBITUX is not indicated for
treatment of RAS-mutant colorectal cancer or when the results of
the RAS mutation tests are unknown
IMPORTANT SAFETY INFORMATION FOR VERZENIO
(abemaciclib)
Diarrhea occurred in 81% of patients receiving
Verzenio plus an aromatase inhibitor in MONARCH 3, 86% of patients
receiving Verzenio plus fulvestrant in MONARCH 2 and 90% of
patients receiving Verzenio alone in MONARCH 1. Grade 3 diarrhea
occurred in 9% of patients receiving Verzenio plus an aromatase
inhibitor in MONARCH 3, 13% of patients receiving Verzenio plus
fulvestrant in MONARCH 2 and in 20% of patients receiving Verzenio
alone in MONARCH 1. Episodes of diarrhea have been associated with
dehydration and infection.
Diarrhea incidence was greatest during the first month of
Verzenio dosing. In MONARCH 3, the median time to onset of the
first diarrhea event was 8 days, and the median duration of
diarrhea for Grades 2 and 3 were 11 and 8 days, respectively. In
MONARCH 2, the median time to onset of the first diarrhea event was
6 days, and the median duration of diarrhea for Grades 2 and 3 were
9 days and 6 days, respectively. In MONARCH 3, 19% of patients with
diarrhea required a dose omission and 13% required a dose
reduction. In MONARCH 2, 22% of patients with diarrhea required a
dose omission and 22% required a dose reduction. The time to onset
and resolution for diarrhea were similar across MONARCH 3, MONARCH
2, and MONARCH 1.
Instruct patients that at the first sign of loose stools, they
should start antidiarrheal therapy such as loperamide, increase
oral fluids, and notify their healthcare provider for further
instructions and appropriate follow-up. For Grade 3 or 4 diarrhea,
or diarrhea that requires hospitalization, discontinue Verzenio
until toxicity resolves to ≤Grade 1, and then resume Verzenio at
the next lower dose.
Neutropenia occurred in 41% of patients receiving
Verzenio plus an aromatase inhibitor in MONARCH 3, 46% of patients
receiving Verzenio plus fulvestrant in MONARCH 2 and 37% of
patients receiving Verzenio alone in MONARCH 1. A Grade ≥3 decrease
in neutrophil count (based on laboratory findings) occurred in 22%
of patients receiving Verzenio plus an aromatase inhibitor in
MONARCH 3, 32% of patients receiving Verzenio plus fulvestrant in
MONARCH 2 and in 27% of patients receiving Verzenio alone in
MONARCH 1. In MONARCH 3, the median time to first episode of Grade
≥3 neutropenia was 33 days, and in MONARCH 2 and MONARCH 1, was 29
days. In MONARCH 3, median duration of Grade ≥3 neutropenia was 11
days, and for MONARCH 2 and MONARCH 1 was 15 days.
Monitor complete blood counts prior to the start of Verzenio
therapy, every 2 weeks for the first 2 months, monthly for the next
2 months, and as clinically indicated. Dose interruption, dose
reduction, or delay in starting treatment cycles is recommended for
patients who develop Grade 3 or 4 neutropenia.
Febrile neutropenia has been reported in <1% of patients
exposed to Verzenio in the MONARCH studies. Two deaths due to
neutropenic sepsis were observed in MONARCH 2. Inform patients to
promptly report any episodes of fever to their healthcare
provider.
Severe, life-threatening, or fatal interstitial lung
disease (ILD) and/or pneumonitis can occur in patients
treated with Verzenio and other CDK4/6 inhibitors. Across clinical
trials (MONARCH 1, MONARCH 2, MONARCH 3), 3.3% of Verzenio-treated
patients had ILD/pneumonitis of any grade, 0.6% had Grade 3 or 4,
and 0.4% had fatal outcomes. Additional cases of ILD/pneumonitis
have been observed in the post-marketing setting, with fatalities
reported.
Monitor patients for pulmonary symptoms indicative of
ILD/pneumonitis. Symptoms may include hypoxia, cough, dyspnea, or
interstitial infiltrates on radiologic exams. Infectious,
neoplastic, and other causes for such symptoms should be excluded
by means of appropriate investigations.
Dose interruption or dose reduction is recommended in patients
who develop persistent or recurrent Grade 2 ILD/pneumonitis.
Permanently discontinue Verzenio in all patients with grade 3 or 4
ILD/pneumonitis.
Grade ≥3 increases in alanine aminotransferase
(ALT) (6% versus 2%) and aspartate
aminotransferase (AST) (3% versus 1%) were reported in the
Verzenio and placebo arms, respectively, in MONARCH 3. Grade ≥3
increases in ALT (4% versus 2%) and AST (2% versus 3%) were
reported in the Verzenio and placebo arms respectively, in MONARCH
2.
In MONARCH 3, for patients receiving Verzenio plus an aromatase
inhibitor with Grade ≥3 increases in ALT or AST, median time to
onset was 61 and 71 days, respectively, and median time to
resolution to Grade <3 was 14 and 15 days, respectively. In
MONARCH 2, for patients receiving Verzenio plus fulvestrant with
Grade ≥3 increases in ALT or AST, median time to onset was 57 and
185 days, respectively, and median time to resolution to Grade
<3 was 14 and 13 days, respectively.
For assessment of potential hepatotoxicity, monitor
liver function tests (LFTs) prior to the start of Verzenio therapy,
every 2 weeks for the first 2 months, monthly for the next 2
months, and as clinically indicated. Dose interruption, dose
reduction, dose discontinuation, or delay in starting treatment
cycles is recommended for patients who develop persistent or
recurrent Grade 2, or Grade 3 or 4, hepatic transaminase
elevation.
Venous thromboembolic events were reported in 5% of
patients treated with Verzenio plus an aromatase inhibitor as
compared to 0.6% of patients treated with an aromatase inhibitor
plus placebo in MONARCH 3. Venous thromboembolic events were
reported in 5% of patients treated with Verzenio plus fulvestrant
in MONARCH 2 as compared to 0.9% of patients treated with
fulvestrant plus placebo. Venous thromboembolic events included
deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis,
cerebral venous sinus thrombosis, subclavian and axillary vein
thrombosis, and inferior vena cava thrombosis. Across the clinical
development program, deaths due to venous thromboembolism have been
reported. Monitor patients for signs and symptoms of venous
thrombosis and pulmonary embolism and treat as medically
appropriate.
Verzenio can cause fetal harm when administered
to a pregnant woman based on findings from animal studies and the
mechanism of action. In animal reproduction studies, administration
of abemaciclib to pregnant rats during the period of organogenesis
caused teratogenicity and decreased fetal weight at maternal
exposures that were similar to the human clinical exposure based on
area under the curve (AUC) at the maximum recommended human dose.
Advise pregnant women of the potential risk to a fetus. Advise
females of reproductive potential to use effective contraception
during treatment with Verzenio and for at least 3 weeks after the
last dose. There are no data on the presence of Verzenio in human
milk or its effects on the breastfed child or on milk production.
Advise lactating women not to breastfeed during Verzenio treatment
and for at least 3 weeks after the last dose because of the
potential for serious adverse reactions in breastfed infants. Based
on findings in animals, Verzenio may impair fertility in males of
reproductive potential.
The most common adverse reactions (all grades,
≥10%) observed in MONARCH 3 for Verzenio plus
anastrozole or letrozole and ≥2% higher than placebo
plus anastrozole or letrozole vs placebo plus anastrozole or
letrozole were diarrhea (81% vs 30%), neutropenia (41% vs
2%), fatigue (40% vs 32%), infections (39% vs 29%), nausea (39% vs
20%), abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia
(28% vs 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%),
leukopenia (21% vs 2%), creatinine increased (19% vs 4%),
constipation (16% vs 12%), ALT increased (16% vs 7%), AST increased
(15% vs 7%), rash (14% vs 5%), pruritus (13% vs 9%), cough (13% vs
9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased
(10% vs 3%), influenza-like illness (10% vs 8%), and
thrombocytopenia (10% vs 2%).
The most common adverse reactions (all grades,
≥10%) observed in MONARCH 2 for Verzenio plus
fulvestrant and ≥2% higher than placebo plus fulvestrant vs placebo
plus fulvestrant were diarrhea (86% vs 25%), neutropenia
(46% vs 4%), fatigue (46% vs 32%), nausea (45% vs 23%), infections
(43% vs 25%), abdominal pain (35% vs 16%), anemia (29% vs 4%),
leukopenia (28% vs 2%), decreased appetite (27% vs 12%), vomiting
(26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 3%),
thrombocytopenia (16% vs 3%), alopecia (16% vs 2%), stomatitis (15%
vs 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough
(13% vs 11%), dizziness (12% vs 6%), AST increased (12% vs 7%),
peripheral edema (12% vs 7%), creatinine increased (12% vs <1%),
rash (11% vs 4%), pyrexia (11% vs 6%), and weight decreased (10% vs
2%).
The most common adverse reactions (all grades,
≥10%) observed in MONARCH 1 with Verzenio
were diarrhea (90%), fatigue (65%), nausea (64%), decreased
appetite (45%), abdominal pain (39%), neutropenia (37%), vomiting
(35%), infections (31%), anemia (25%), thrombocytopenia (20%),
headache (20%), cough (19%), leukopenia (17%), constipation (17%),
arthralgia (15%), dry mouth (14%), weight decreased (14%),
stomatitis (14%), creatinine increased (13%), alopecia (12%),
dysgeusia (12%), pyrexia (11%), dizziness (11%), and dehydration
(10%).
The most frequently reported ≥5% Grade 3 or 4 adverse
reactions that occurred in the Verzenio arm vs the placebo
arm of MONARCH 3 were neutropenia (22% vs 2%),
diarrhea (9% vs 1%), leukopenia (8% vs <1%), ALT increased (7%
vs 2%), and anemia (6% vs 1%).
The most frequently reported ≥5% Grade 3 or 4 adverse
reactions that occurred in the Verzenio arm vs the placebo
arm of MONARCH 2 were neutropenia (27% vs 2%),
diarrhea (13% vs <1%), leukopenia (9% vs 0%), anemia (7% vs 1%),
and infections (6% vs 3%).
The most frequently reported ≥5% Grade 3 or 4 adverse
reactions from MONARCH 1 with Verzenio
were neutropenia (24%), diarrhea (20%), fatigue (13%), infections
(7%), leukopenia (6%), anemia (5%), and nausea (5%).
Lab abnormalities (all grades; Grade 3 or
4) for MONARCH 3 in ≥10% for Verzenio plus
anastrozole or letrozole and ≥2% higher than placebo plus
anastrozole or letrozole vs placebo plus anastrozole or
letrozole were increased serum creatinine (98% vs 84%; 2%
vs 0%), decreased white blood cells (82% vs 27%; 13% vs <1%),
anemia (82% vs 28%; 2% vs 0%), decreased neutrophil count (80% vs
21%; 22% vs 3%), decreased lymphocyte count (53% vs 26%; 8% vs 2%),
decreased platelet count (36% vs 12%; 2% vs <1%), increased ALT
(48% vs 25%; 7% vs 2%), and increased AST (37% vs 23%; 4% vs
<1%).
Lab abnormalities (all grades; Grade 3 or
4) for MONARCH 2 in ≥10% for Verzenio plus
fulvestrant and ≥2% higher than placebo plus fulvestrant vs placebo
plus fulvestrant were increased serum creatinine (98% vs
74%; 1% vs 0%), decreased white blood cells (90% vs 33%; 23% vs
1%), decreased neutrophil count (87% vs 30%; 33% vs 4%), anemia
(84% vs 33%; 3% vs <1%), decreased lymphocyte count (63% vs 32%;
12% vs 2%), decreased platelet count (53% vs 15%; 2% vs 0%),
increased ALT (41% vs 32%; 5% vs 1%), and increased AST (37% vs
25%; 4% vs 4%).
Lab abnormalities (all grades; Grade 3 or 4) for MONARCH
1 were increased serum creatinine (98%; <1%), decreased
white blood cells (91%; 28%), decreased neutrophil count (88%;
27%), anemia (68%; 0%), decreased lymphocyte count (42%; 14%),
decreased platelet count (41%; 2%), increased ALT (31%; 3%), and
increased AST (30%; 4%).
Strong and moderate CYP3A inhibitors increased the
exposure of abemaciclib plus its active metabolites to a clinically
meaningful extent and may lead to increased toxicity. Avoid
concomitant use of the strong CYP3A inhibitor ketoconazole.
Ketoconazole is predicted to increase the AUC of abemaciclib by up
to 16-fold. In patients with recommended starting doses of 200 mg
twice daily or 150 mg twice daily, reduce the Verzenio dose to 100
mg twice daily with concomitant use of strong CYP3A inhibitors
other than ketoconazole. In patients who have had a dose reduction
to 100 mg twice daily due to adverse reactions, further reduce the
Verzenio dose to 50 mg twice daily with concomitant use of strong
CYP3A inhibitors. If a patient taking Verzenio discontinues a
strong CYP3A inhibitor, increase the Verzenio dose (after 3 to 5
half-lives of the inhibitor) to the dose that was used before
starting the inhibitor. With concomitant use of moderate CYP3A
inhibitors, monitor for adverse reactions and consider reducing the
Verzenio dose in 50 mg decrements. Patients should avoid grapefruit
products.
Avoid concomitant use of strong or moderate CYP3A inducers
and consider alternative agents. Coadministration of
strong or moderate CYP3A inducers decreased the plasma
concentrations of abemaciclib plus its active metabolites and may
lead to reduced activity.
With severe hepatic impairment (Child-Pugh Class C),
reduce the Verzenio dosing frequency to once daily. The
pharmacokinetics of Verzenio in patients with severe renal
impairment (CLcr <30 mL/min), end stage renal disease,
or in patients on dialysis is unknown. No dosage
adjustments are necessary in patients with mild or moderate hepatic
(Child-Pugh A or B) and/or renal impairment (CLcr ≥30-89
mL/min).
AL HCP ISI 17SEP2019
Please see full Prescribing
Information for Verzenio.
IMPORTANT SAFETY INFORMATION FOR
RETEVMO® (selpercatinib)
Hepatotoxicity: Serious hepatic adverse reactions
occurred in 2.6% of patients treated with Retevmo. Increased
aspartate aminotransferase (AST) occurred in 51% of patients,
including Grade 3 or 4 events in 8% and increased alanine
aminotransferase (ALT) occurred in 45% of patients, including Grade
3 or 4 events in 9%. The median time to first onset for increased
AST was 4.1 weeks (range: 5 days to 2 years) and increased ALT was
4.1 weeks (range: 6 days to 1.5 years). Monitor ALT and AST prior
to initiating Retevmo, every 2 weeks during the first 3 months,
then monthly thereafter and as clinically indicated. Withhold,
reduce dose or permanently discontinue Retevmo based on the
severity.
Hypertension occurred in 35% of patients, including
Grade 3 hypertension in 17% and Grade 4 in one (0.1%) patient.
Overall, 4.6% had their dose interrupted and 1.3% had their dose
reduced for hypertension. Treatment-emergent hypertension was most
commonly managed with anti-hypertension medications. Do not
initiate Retevmo in patients with uncontrolled hypertension.
Optimize blood pressure prior to initiating Retevmo. Monitor blood
pressure after 1 week, at least monthly thereafter, and as
clinically indicated. Initiate or adjust anti-hypertensive therapy
as appropriate. Withhold, reduce dose, or permanently discontinue
Retevmo based on the severity.
Retevmo can cause concentration-dependent QT interval
prolongation. An increase in QTcF interval to >500 ms was
measured in 6% of patients and an increase in the QTcF interval of
at least 60 ms over baseline was measured in 15% of patients.
Retevmo has not been studied in patients with clinically
significant active cardiovascular disease or recent myocardial
infarction. Monitor patients who are at significant risk of
developing QTc prolongation, including patients with known long QT
syndromes, clinically significant bradyarrhythmias, and severe or
uncontrolled heart failure. Assess QT interval, electrolytes and
TSH at baseline and periodically during treatment, adjusting
frequency based upon risk factors including diarrhea. Correct
hypokalemia, hypomagnesemia and hypocalcemia prior to initiating
Retevmo and during treatment. Monitor the QT interval more
frequently when Retevmo is concomitantly administered with strong
and moderate CYP3A inhibitors or drugs known to prolong QTc
interval. Withhold and dose reduce or permanently discontinue
Retevmo based on the severity.
Serious, including fatal, hemorrhagic events can occur
with Retevmo. Grade ≥3 hemorrhagic events occurred in 2.3% of
patients treated with Retevmo including 3 (0.4%) patients with
fatal hemorrhagic events, including one case each of cerebral
hemorrhage, tracheostomy site hemorrhage, and hemoptysis.
Permanently discontinue Retevmo in patients with severe or
life-threatening hemorrhage.
Hypersensitivity occurred in 4.3% of patients
receiving Retevmo, including Grade 3 hypersensitivity in 1.6%. The
median time to onset was 1.7 weeks (range 6 days to 1.5 years).
Signs and symptoms of hypersensitivity included fever, rash and
arthralgias or myalgias with concurrent decreased platelets or
transaminitis. If hypersensitivity occurs, withhold Retevmo and
begin corticosteroids at a dose of 1 mg/kg prednisone (or
equivalent). Upon resolution of the event, resume Retevmo at a
reduced dose and increase the dose of Retevmo by 1 dose level each
week as tolerated until reaching the dose taken prior to onset of
hypersensitivity. Continue steroids until patient reaches target
dose and then taper. Permanently discontinue Retevmo for recurrent
hypersensitivity.
Tumor lysis syndrome (TLS) occurred in 1% of
patients with medullary thyroid carcinoma receiving Retevmo.
Patients may be at risk of TLS if they have rapidly growing tumors,
a high tumor burden, renal dysfunction, or dehydration. Closely
monitor patients at risk, consider appropriate prophylaxis
including hydration, and treat as clinically indicated.
Impaired wound healing can occur in patients who
receive drugs that inhibit the vascular endothelial growth factor
(VEGF) signaling pathway. Therefore, Retevmo has the potential to
adversely affect wound healing. Withhold Retevmo for at least 7
days prior to elective surgery. Do not administer for at least 2
weeks following major surgery and until adequate wound healing. The
safety of resumption of Retevmo after resolution of wound healing
complications has not been established.
Based on data from animal reproduction studies and its mechanism
of action, Retevmo can cause fetal harm when administered to
a pregnant woman. Administration of selpercatinib to pregnant rats
during organogenesis at maternal exposures that were approximately
equal to those observed at the recommended human dose of 160 mg
twice daily resulted in embryolethality and malformations. Advise
pregnant women of the potential risk to a fetus. Advise females of
reproductive potential and males with female partners of
reproductive potential to use effective contraception during
treatment with Retevmo and for at least 1 week after the final
dose. There are no data on the presence of selpercatinib or its
metabolites in human milk or on their effects on the breastfed
child or on milk production. Because of the potential for serious
adverse reactions in breastfed children, advise women not to
breastfeed during treatment with Retevmo and for 1 week after the
final dose.
Severe adverse reactions (Grade 3-4) occurring in ≥15% of
patients who received Retevmo in LIBRETTO-001, were
hypertension (18%), prolonged QT interval (4%), diarrhea (3.4%),
dyspnea (2.3%), fatigue (2%), abdominal pain (1.9%), hemorrhage
(1.9%), headache (1.4%), rash (0.7%), constipation (0.6%), nausea
(0.6%), vomiting (0.3%), and edema (0.3%).
Serious adverse reactions occurred in 33% of
patients who received Retevmo. The most frequently reported serious
adverse reaction (in ≥ 2% of patients) was pneumonia.
Fatal adverse reactions occurred in 3% of patients; fatal
adverse reactions which occurred in >1 patient included sepsis
(n=3), cardiac arrest (n=3) and respiratory failure (n=3).
Common adverse reactions (all grades) occurring in ≥15% of
patients who received Retevmo in LIBRETTO-001, were dry mouth
(39%), diarrhea (37%), hypertension (35%), fatigue (35%), edema
(35%), rash (27%), constipation (25%), nausea (23%), abdominal pain
(23%), headache (23%), cough (18%), prolonged QT interval (17%),
dyspnea (16%), vomiting (15%), and hemorrhage (15%).
Laboratory abnormalities (all grades; Grade 3-4) ≥20%
worsening from baseline in patients who received Retevmo in
LIBRETTO-001, were AST increased (51%; 8%), ALT increased (45%;
9%), increased glucose (44%; 2.2%), decreased leukocytes (43%;
1.6%), decreased albumin (42%; 0.7%), decreased calcium (41%;
3.8%), increased creatinine (37%; 1.0%), increased alkaline
phosphatase (36%; 2.3%), decreased platelets (33%; 2.7%), increased
total cholesterol (31%; 0.1%), decreased sodium (27%; 7%),
decreased magnesium (24%; 0.6%), increased potassium (24%; 1.2%),
increased bilirubin (23%; 2.0%), and decreased glucose (22%;
0.7%).
Concomitant use of acid-reducing agents decreases
selpercatinib plasma concentrations which may reduce Retevmo
anti-tumor activity. Avoid concomitant use of proton-pump
inhibitors (PPIs), histamine-2 (H2) receptor antagonists, and
locally-acting antacids with Retevmo. If coadministration cannot be
avoided, take Retevmo with food (with a PPI) or modify its
administration time (with a H2 receptor antagonist or a
locally-acting antacid).
Concomitant use of strong and moderate CYP3A inhibitors
increases selpercatinib plasma concentrations which may increase
the risk of Retevmo adverse reactions including QTc interval
prolongation. Avoid concomitant use of strong and moderate
CYP3A inhibitors with Retevmo. If concomitant use of a strong or
moderate CYP3A inhibitor cannot be avoided, reduce the Retevmo
dosage as recommended and monitor the QT interval with ECGs more
frequently.
Concomitant use of strong and moderate CYP3A inducers
decreases selpercatinib plasma concentrations which may reduce
Retevmo anti-tumor activity. Avoid coadministration of Retevmo with
strong and moderate CYP3A inducers.
Concomitant use of Retevmo with CYP2C8 and CYP3A
substrates increases their plasma concentrations which may
increase the risk of adverse reactions related to these substrates.
Avoid coadministration of Retevmo with CYP2C8 and CYP3A substrates
where minimal concentration changes may lead to increased adverse
reactions. If coadministration cannot be avoided, follow
recommendations for CYP2C8 and CYP3A substrates provided in their
approved product labeling.
The safety and effectiveness of Retevmo have not been
established in pediatric patients less than 12 years of
age. The safety and effectiveness of Retevmo have been
established in pediatric patients aged 12 years and older for
medullary thyroid cancer (MTC) who require systemic therapy and for
advanced RET fusion-positive thyroid cancer who require
systemic therapy and are radioactive iodine-refractory (if
radioactive iodine is appropriate). Use of Retevmo for these
indications is supported by evidence from adequate and
well-controlled studies in adults with additional pharmacokinetic
and safety data in pediatric patients aged 12 years and
older. Monitor open growth plates in adolescent
patients. Consider interrupting or discontinuing Retevmo if
abnormalities occur.
No dosage modification is recommended for patients with mild
to severe renal impairment (estimated Glomerular Filtration
Rate [eGFR] ≥15 to 89 mL/min, estimated by Modification of Diet in
Renal Disease [MDRD] equation). A recommended dosage has not been
established for patients with end-stage renal disease.
Reduce the dose when administering Retevmo to patients with
severe hepatic impairment (total bilirubin greater than 3 to
10 times upper limit of normal [ULN] and any AST). No dosage
modification is recommended for patients with mild or moderate
hepatic impairment. Monitor for Retevmo-related adverse reactions
in patients with hepatic impairment.
SE HCP ISI All_25MAR2021
Please see full U.S. Prescribing Information for
Retevmo.
IMPORTANT SAFETY INFORMATION FOR CYRAMZA®
(ramucirumab)
Warnings and Precautions
Hemorrhage
- CYRAMZA increased the risk of hemorrhage and gastrointestinal
hemorrhage, including Grade ≥3 hemorrhagic events. In 2137 patients
with various cancers treated with CYRAMZA, the incidence of all
Grade hemorrhage ranged from 13-55%. Grade 3-5 hemorrhage incidence
ranged from 2-5%.
- Patients with gastric cancer receiving nonsteroidal
anti-inflammatory drugs (NSAIDs) were excluded from enrollment in
REGARD and RAINBOW; therefore, the risk of gastric hemorrhage in
CYRAMZA-treated patients with gastric tumors receiving NSAIDs is
unknown.
- Patients with NSCLC receiving therapeutic anticoagulation or
with evidence of major airway invasion by cancer were excluded from
REVEL. In addition, patients with NSCLC with a recent history of
gross hemoptysis, those receiving chronic therapy with NSAIDs or
other anti-platelet therapy other than once daily aspirin or with
radiographic evidence of major blood vessel invasion or intratumor
cavitation were excluded from REVEL and RELAY; therefore the risk
of pulmonary hemorrhage in these groups of patients is
unknown.
- Permanently discontinue CYRAMZA in patients who experience
severe (Grade 3 or 4) bleeding.
Gastrointestinal Perforations
- CYRAMZA can increase the risk of gastrointestinal perforation,
a potentially fatal event. In 2137 patients with various cancers
treated with CYRAMZA, the incidence of all Grade and Grade 3-5
gastrointestinal perforations ranged from <1-2%.
- Permanently discontinue CYRAMZA in patients who experience a
gastrointestinal perforation.
Impaired Wound Healing
- CYRAMZA has the potential to adversely affect wound healing.
CYRAMZA has not been studied in patients with serious or
non-healing wounds.
- Withhold CYRAMZA for 28 days prior to elective surgery. Do not
administer CYRAMZA for at least 2 weeks following a major surgical
procedure and until adequate wound healing. The safety of
resumption of CYRAMZA after resolution of wound healing
complications has not been established.
Arterial Thromboembolic Events (ATEs)
- Serious, sometimes fatal, ATEs, including myocardial
infarction, cardiac arrest, cerebrovascular accident, and cerebral
ischemia, occurred across clinical trials. In 2137 patients with
various cancers treated with CYRAMZA, the incidence of all Grade
ATE was 1-3%. Grade 3-5 ATE incidence was <1-2%.
- Permanently discontinue CYRAMZA in patients who experience an
ATE.
Hypertension
- An increased incidence of severe hypertension occurred in
patients receiving CYRAMZA. Across five clinical studies, excluding
RELAY, in 1916 patients with various cancers treated with CYRAMZA,
the incidence of all Grade hypertension ranged from 11-26%. Grade
3-5 hypertension incidence ranged from 6-15%. In 221 patients with
NSCLC receiving CYRAMZA in combination with erlotinib in the RELAY
study, the incidence of new or worsening hypertension was higher
(45%), as was the incidence of Grade 3-5 hypertension (24%). Of the
patients experiencing new or worsening hypertension in RELAY (N=100
CYRAMZA and erlotinib; N=27 placebo and erlotinib), 13% of those
treated with CYRAMZA and erlotinib required initiation of 3 or more
antihypertensive medications compared to 4% of patients treated
with placebo and erlotinib.
- Control hypertension prior to initiating treatment with
CYRAMZA. Monitor blood pressure every two weeks or more frequently
as indicated during treatment. Withhold CYRAMZA for severe
hypertension until medically controlled. Permanently discontinue
CYRAMZA for medically significant hypertension that cannot be
controlled with antihypertensive therapy or in patients with
hypertensive crisis or hypertensive encephalopathy.
Infusion-Related Reactions (IRR)
- IRR, including severe and life-threatening IRR, occurred in
CYRAMZA clinical trials. Symptoms of IRR included rigors/tremors,
back pain/spasms, chest pain and/or tightness, chills, flushing,
dyspnea, wheezing, hypoxia, and paresthesia. In severe cases,
symptoms included bronchospasm, supraventricular tachycardia, and
hypotension. In 2137 patients with various cancers treated with
CYRAMZA in which premedication was recommended or required, the
incidence of all Grade IRR ranged from <1- 9%. Grade
3-5 IRR incidence was <1%.
- Premedicate prior to each CYRAMZA infusion. Monitor patients
during the infusion for signs and symptoms of IRR in a setting with
available resuscitation equipment. Reduce the infusion rate by 50%
for Grade 1-2 IRR. Permanently
discontinue CYRAMZA for Grade 3- 4
IRR.
Worsening of Pre-existing Hepatic Impairment
- Clinical deterioration, manifested by new onset or worsening
encephalopathy, ascites, or hepatorenal syndrome, was reported in
patients with Child-Pugh B or C cirrhosis who received single agent
CYRAMZA. Use CYRAMZA in patients with Child-Pugh B or C cirrhosis
only if the potential benefits of treatment are judged to outweigh
the risks of clinical deterioration.
- Based on safety data from REACH-2, in patients with Child-Pugh
A liver cirrhosis, the pooled incidence of hepatic encephalopathy
and hepatorenal syndrome was higher for patients who received
CYRAMZA (6%) compared to patients who received placebo (0%).
Posterior Reversible Encephalopathy Syndrome (PRES)
- PRES (also known as Reversible Posterior Leukoencephalopathy
Syndrome [RPLS]) has been reported in <0.1% of 2137 patients
with various cancers treated with CYRAMZA. Symptoms of PRES include
seizure, headache, nausea/vomiting, blindness, or altered
consciousness, with or without associated hypertension.
- Permanently discontinue CYRAMZA in patients who develop PRES.
Symptoms may resolve or improve within days, although some patients
with PRES can experience ongoing neurologic sequelae or death.
Proteinuria Including Nephrotic Syndrome
- In 2137 patients with various cancers treated with CYRAMZA, the
incidence of all Grade proteinuria ranged from 3-34%. Grade ≥3
proteinuria (including 4 patients with nephrotic syndrome)
incidence ranged from <1-3%.
- Monitor for proteinuria. Withhold CYRAMZA for urine protein
levels that are 2 or more grams over 24 hours. Reinitiate CYRAMZA
at a reduced dose once the urine protein level returns to less than
2 grams over 24 hours. Permanently discontinue CYRAMZA for urine
protein levels greater than 3 grams over 24 hours or in the setting
of nephrotic syndrome.
Thyroid Dysfunction
- In 2137 patients with various cancers treated with CYRAMZA, the
incidence of Grade 1-2 hypothyroidism ranged from <1-3%; there
were no reports of Grade 3-5 hypothyroidism. Monitor thyroid
function during treatment with CYRAMZA.
Embryo-Fetal Toxicity
- CYRAMZA can cause fetal harm when administered to pregnant
women. Advise pregnant women of the potential risk to a fetus.
Advise females of reproductive potential to use effective
contraception during treatment with CYRAMZA and for 3 months after
the last dose.
Lactation
- Because of the potential risk for serious adverse reactions in
breastfed children from ramucirumab, advise women not to breastfeed
during treatment with CYRAMZA and for 2 months after the last
dose.
Adverse Reactions
REGARD:
- The most common adverse reactions (all Grades) observed in
single agent CYRAMZA-treated gastric cancer patients at a rate of
≥5% and ≥2% higher than placebo were hypertension (16% vs 8%),
diarrhea (14% vs 9%), headache (9% vs 3%), and hyponatremia (6% vs
2%).
- The most common serious adverse reactions with CYRAMZA were
anemia (3.8%) and intestinal obstruction (2.1%). Red blood cell
transfusions were given to 11% of CYRAMZA-treated patients vs 8.7%
of patients who received placebo.
- Clinically relevant adverse reactions reported in ≥1% and
<5% of CYRAMZA-treated patients in REGARD were neutropenia
(4.7%), epistaxis (4.7%), rash (4.2%), intestinal obstruction
(2.1%), and arterial thromboembolic events (1.7%).
- Across clinical trials of CYRAMZA administered as a single
agent, clinically relevant adverse reactions (including Grade ≥3)
reported in CYRAMZA-treated patients included proteinuria,
gastrointestinal perforation, and IRR. In REGARD, according to
laboratory assessment, 8% of CYRAMZA-treated patients developed
proteinuria vs 3% of placebo-treated patients. Two patients
discontinued CYRAMZA due to proteinuria. The rate of
gastrointestinal perforation in REGARD was 0.8% and the rate of IRR
was 0.4%.
RAINBOW:
- The most common adverse reactions (all Grades) observed in
patients treated with CYRAMZA with paclitaxel at a rate of ≥5% and
≥2% higher than placebo with paclitaxel were fatigue/asthenia (57%
vs 44%), neutropenia (54% vs 31%), diarrhea (32% vs 23%), epistaxis
(31% vs 7%), hypertension (25% vs 6%), peripheral edema (25% vs
14%), stomatitis (20% vs 7%), proteinuria (17% vs 6%),
thrombocytopenia (13% vs 6%), hypoalbuminemia (11% vs 5%), and
gastrointestinal hemorrhage events (10% vs 6%).
- The most common serious adverse reactions with CYRAMZA with
paclitaxel were neutropenia (3.7%) and febrile neutropenia (2.4%);
19% of patients who received CYRAMZA with paclitaxel received
granulocyte colony-stimulating factors.
- Adverse reactions resulting in discontinuation of any component
of the CYRAMZA with paclitaxel combination in ≥2% of patients in
RAINBOW were neutropenia (4%) and thrombocytopenia (3%).
- Clinically relevant adverse reactions reported in ≥1% and
<5% of patients receiving CYRAMZA with paclitaxel were sepsis
(3.1%), including 5 fatal events, and gastrointestinal perforations
(1.2%), including 1 fatal event.
REVEL:
- The most common adverse reactions (all Grades) observed in
patients treated with CYRAMZA with docetaxel at a rate of ≥5% and
≥2% higher than placebo with docetaxel were neutropenia (55% vs
46%), fatigue/asthenia (55% vs 50%), stomatitis/mucosal
inflammation (37% vs 19%), epistaxis (19% vs 7%), febrile
neutropenia (16% vs 10%), peripheral edema (16% vs 9%),
thrombocytopenia (13% vs 5%), lacrimation increased (13% vs 5%),
and hypertension (11% vs 5%).
- The most common serious adverse reactions with CYRAMZA with
docetaxel were febrile neutropenia (14%), pneumonia (6%), and
neutropenia (5%). The use of granulocyte colony-stimulating factors
was 42% in CYRAMZA with docetaxel- treated patients versus 37% in
patients who received placebo with docetaxel.
- Treatment discontinuation due to adverse reactions occurred
more frequently in CYRAMZA with docetaxel-treated patients (9%)
than in placebo with docetaxel-treated patients (5%). The most
common adverse reactions leading to treatment discontinuation of
CYRAMZA were IRR (0.5%) and epistaxis (0.3%).
- For patients with non-squamous histology, the overall incidence
of pulmonary hemorrhage was 7% and the incidence of Grade ≥3
pulmonary hemorrhage was 1% for CYRAMZA with docetaxel compared to
6% overall incidence and 1% for Grade ≥3 pulmonary hemorrhage for
placebo with docetaxel. For patients with squamous histology, the
overall incidence of pulmonary hemorrhage was 10% and the incidence
of Grade ≥3 pulmonary hemorrhage was 2% for CYRAMZA with docetaxel
compared to 12% overall incidence and 2% for Grade ≥3 pulmonary
hemorrhage for placebo with docetaxel.
- Clinically relevant adverse reactions reported in ≥1% and
<5% of CYRAMZA with docetaxel-treated patients in REVEL were
hyponatremia (4.8%) and proteinuria (3.3%).
RELAY:
- The most common adverse reactions (all Grades) observed in
patients treated with CYRAMZA with erlotinib at a rate of ≥ 5% and
≥2% higher than placebo with erlotinib were infections (81% vs
76%), diarrhea (70% vs 71%), hypertension (45% vs 12%), stomatitis
(42% vs 36%), alopecia (34% vs 20%), epistaxis (34% vs 12%),
proteinuria (34% vs 8%), peripheral edema (23% vs 4%), headache
(15% vs 7%), gastrointestinal hemorrhage (10% vs 3%), gingival
bleeding (9% vs 1%), and pulmonary hemorrhage (7% vs 2%).
- The most common serious adverse reactions with CYRAMZA with
erlotinib were pneumonia (3.2%), cellulitis (1.8%), and
pneumothorax (1.8%). Red blood cell transfusions were given to 3.2%
of CYRAMZA-treated patients versus 0 patients who received
placebo.
- Treatment discontinuation of all study drugs due to adverse
reactions occurred in 13% of CYRAMZA with erlotinib-treated
patients, with increased alanine aminotransferase (1.4%) and
paronychia (1.4%) being the most common. The most common adverse
reactions leading to treatment discontinuation of CYRAMZA were
proteinuria (8.6%) and hyperbilirubinemia (6%).
- Of the 221 patients who received CYRAMZA with erlotinib, 119
(54%) were 65 and over, while 29 (13%) were 75 and over. Adverse
reactions occurring at a 10% or higher incidence in patients
receiving CYRAMZA with erlotinib and with a 10% or greater
difference between patients aged 65 or older compared to patients
aged less than 65 years were: diarrhea (75% versus 65%),
hypertension (50% versus 40%), increased ALT (49% versus 35%),
increased AST (49% versus 33%), stomatitis (46% versus 36%),
decreased appetite (32% versus 19%), dysgeusia (23% versus 12%),
and weight loss (19% versus 6%).
RAISE:
- The most common adverse reactions (all Grades) observed in
patients treated with CYRAMZA with FOLFIRI at a rate of ≥5% and ≥2%
higher than placebo with FOLFIRI were diarrhea (60% vs 51%),
neutropenia (59% vs 46%), decreased appetite (37% vs 27%),
epistaxis (33% vs 15%), stomatitis (31% vs 21%), thrombocytopenia
(28% vs 14%), hypertension (26% vs 9%), peripheral edema (20% vs
9%), proteinuria (17% vs 5%), palmar-plantar erythrodysesthesia
syndrome (13% vs 5%), gastrointestinal hemorrhage events (12% vs
7%), and hypoalbuminemia (6% vs 2%). Twenty percent of patients
treated with CYRAMZA with FOLFIRI received granulocyte colony-
stimulating factors.
- The most common serious adverse reactions with CYRAMZA with
FOLFIRI were diarrhea (3.6%), intestinal obstruction (3.0%), and
febrile neutropenia (2.8%).
- Treatment discontinuation of any study drug due to adverse
reactions occurred more frequently in CYRAMZA with FOLFIRI-treated
patients (29%) than in placebo with FOLFIRI-treated patients (13%).
The most common adverse reactions leading to discontinuation of any
component of CYRAMZA with FOLFIRI as compared to placebo with
FOLFIRI were neutropenia (12.5% vs 5.3%) and thrombocytopenia (4.2%
vs 0.8%). The most common adverse reactions leading to treatment
discontinuation of CYRAMZA were proteinuria (1.5%), and
gastrointestinal perforation (1.7%).
- Clinically relevant adverse reaction reported in ≥1% and <5%
of patients receiving CYRAMZA with FOLFIRI was gastrointestinal
perforation (1.7%), including 4 fatal events.
- Thyroid-stimulating hormone (TSH) levels were evaluated in 224
patients (115 CYRAMZA with FOLFIRI-treated patients and 109 placebo
with FOLFIRI-treated patients) with normal baseline TSH levels.
Increased TSH levels were observed in 53 (46%) patients treated
with CYRAMZA with FOLFIRI compared with 4 (4%) patients treated
with placebo with FOLFIRI.
REACH-2:
- The most common adverse reactions (all Grades) observed in
single agent CYRAMZA-treated HCC patients at a rate of ≥10% and ≥2%
higher than placebo were fatigue (36% vs 20%), peripheral edema
(25% vs 14%), hypertension (25% vs 13%), abdominal pain (25% vs
16%), decreased appetite (23% vs 20%), proteinuria (20% vs 4%),
nausea (19% vs 12%), ascites (18% vs 7%), headache (14% vs 5%),
epistaxis (14% vs 3%), insomnia (11% vs 6%), pyrexia (10% vs 3%),
vomiting (10% vs 7%), and back pain (10% vs 7%).
- The most common serious adverse reactions with CYRAMZA were
ascites (3%) and pneumonia (3%).
- Treatment discontinuations due to adverse reactions occurred in
18% of CYRAMZA-treated patients, with proteinuria being the most
frequent (2%).
- Clinically relevant adverse reactions reported in ≥1% and
<10% of CYRAMZA-treated patients in REACH-2 were IRR (9%),
hepatic encephalopathy (5%) including 1 fatal event, and
hepatorenal syndrome (2%) including 1 fatal event.
RB-P HCP ISI 29MAY2020
Please see full U.S. Prescribing Information for
CYRAMZA.
IMPORTANT SAFETY INFORMATION FOR ERBITUX® (cetuximab)
WARNING:
INFUSION REACTIONS AND CARDIOPULMONARY ARREST
Infusion
Reactions
- ERBITUX can
cause serious and fatal infusion reactions. Severe (Grades 3 and 4)
infusion reactions occurred in 2.2% of patients receiving ERBITUX
in clinical trials.
- The risk of
anaphylactic reactions may be increased in patients with a history
of tick bites, red meat allergy, or in the presence of IgE
antibodies directed against galactose-α-1,3-galactose (alpha-gal).
Consider testing patients for alpha-gal IgE antibodies using
FDA-cleared methods prior to initiating ERBITUX. Negative results
for alpha-gal antibodies do not rule out the risk of severe
infusion reactions.
- Approximately
90% of the severe infusion reactions occurred with the first
infusion of ERBITUX despite premedication with
antihistamines.
-
- Serious infusion
reactions, requiring immediate medical intervention, included
symptoms of rapid onset of airway obstruction (bronchospasm,
stridor, hoarseness), hypotension, shock, loss of consciousness,
myocardial infarction, and/or cardiac arrest. Immediately interrupt
and permanently discontinue ERBITUX infusion for serious infusion
reactions.
- Caution must be
exercised with every ERBITUX infusion as infusion reactions may
occur during or several hours following completion of the
infusion.
- Premedicate with
a histamine-1 (H1) receptor antagonist as
recommended.
- Monitor patients
for at least 1 hour following each ERBITUX infusion in a setting
with resuscitation equipment and other agents necessary to treat
anaphylaxis. In patients requiring treatment for infusion
reactions, monitor for more than 1 hour to confirm resolution of
the reaction. Interrupt the infusion and upon recovery, resume the
infusion at a slower rate or permanently discontinue ERBITUX based
on severity.
Cardiopulmonary
Arrest
- ERBITUX can
cause cardiopulmonary arrest. Cardiopulmonary arrest or
sudden death occurred in 2% of 208 patients with squamous cell
carcinoma of the head and neck receiving radiation therapy and
ERBITUX in BONNER. In 3 patients with prior history of
coronary artery disease, death occurred 27, 32, and 43 days
respectively after the last dose of ERBITUX. One patient with
no prior history of coronary artery disease died one day after the
last dose of ERBITUX. In EXTREME, fatal cardiac disorders and/or
sudden death occurred in 3% of the 219 patients with squamous cell
carcinoma of the head and neck treated with a cetuximab product in
combination with platinum-based therapy and
fluorouracil.
-
- Carefully
consider the use of ERBITUX with radiation therapy, or with
platinum-based therapy with fluorouracil, in head and neck cancer
patients with a history of coronary artery disease, congestive
heart failure, or arrhythmias.
- Closely monitor
serum electrolytes, including serum magnesium, potassium, and
calcium, during and after ERBITUX therapy.
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Pulmonary Toxicity
- ERBITUX can cause interstitial lung disease (ILD). ILD, which
was fatal in one case, occurred in <0.5% of 1570 patients
receiving ERBITUX in clinical trials. Monitor patients for signs
and symptoms of pulmonary toxicity. Interrupt or permanently
discontinue ERBITUX for acute onset or worsening of pulmonary
symptoms. Permanently discontinue ERBITUX for confirmed ILD.
Dermatologic Toxicities
- ERBITUX can cause dermatologic toxicities, including acneiform
rash, skin drying and fissuring, paronychial inflammation,
infectious sequelae (e.g., S. aureus sepsis, abscess formation,
cellulitis, blepharitis, conjunctivitis, keratitis/ulcerative
keratitis with decreased visual acuity, cheilitis), and
hypertrichosis
-
- Acneiform rash occurred in 82% of the 1373 patients who
received ERBITUX across clinical trials. Severe (Grades 3 or 4)
acneiform rash occurred in 9.7% of patients. Acneiform rash usually
developed within the first 2 weeks of therapy; the rash lasted more
than 28 days after stopping ERBITUX in most patients.
- Life-threatening and fatal bullous mucocutaneous disease with
blisters, erosions, and skin sloughing has been observed in
patients who received ERBITUX. It could not be determined whether
these mucocutaneous adverse reactions were directly related to EGFR
inhibition or to idiosyncratic immune-related effects (e.g.,
Stevens-Johnson syndrome or toxic epidermal necrolysis).
- Monitor patients receiving ERBITUX for dermatologic toxicities
and infectious sequelae.
- Sun exposure may exacerbate these effects. Instruct patients to
limit sun exposure during ERBITUX therapy.
- Withhold, reduce dose or permanently discontinue ERBITUX based
on severity of acneiform rash or mucocutaneous disease.
Risks Associated with Use in Combination with Radiation and
Cisplatin
- ERBITUX is not indicated for the treatment of SCCHN in
combination with radiation and cisplatin.
- In a controlled study, 940 patients with locally advanced SCCHN
were randomized 1:1 to receive either ERBITUX in combination with
radiation therapy and cisplatin, or radiation therapy and cisplatin
alone. The addition of ERBITUX resulted in an increase in the
incidence of Grade 3 and 4 mucositis, radiation recall syndrome,
acneiform rash, cardiac events, and electrolyte disturbances
compared to radiation and cisplatin alone.
- Adverse reactions with fatal outcome were reported in 4% of
patients in the ERBITUX combination arm and 3% in the control
arm.
- In the ERBITUX arm, 2% experienced myocardial ischemia compared
to 0.9% in the control arm.
- The addition of ERBITUX to radiation and cisplatin did not
improve progression-free survival (the primary endpoint).
Hypomagnesemia and Accompanying Electrolyte
Abnormalities
- ERBITUX can cause hypomagnesemia. Hypomagnesemia occurred in
55% of 365 patients receiving ERBITUX in study CA225-025 and two
other clinical trials in patients with colorectal cancer (CRC) or
head and neck cancer, including Grades 3 and 4 in 6% to 17%. In
EXTREME, where a cetuximab product was administered in combination
with platinum-based therapy, the addition cetuximab to cisplatin
and fluorouracil resulted in an increased incidence of
hypomagnesemia of any grade (14%) and of Grade 3 or 4
hypomagnesemia (7%). Hypomagnesemia of any grade occurred in 4% of
patients who received cetuximab, carboplatin, and fluorouracil. No
patient experienced grade 3 or 4 hypomagnesemia. The onset of
hypomagnesemia and accompanying electrolyte abnormalities can occur
days to months after initiating ERBITUX.
-
- Monitor patients weekly during treatment for hypomagnesemia,
hypocalcemia, and hypokalemia, and for at least 8 weeks following
the completion of ERBITUX.
- Replete electrolytes as necessary.
Increased Tumor Progression, Increased Mortality, or Lack of
Benefit in Patients with Ras--Mutant mCRC
- ERBITUX is not indicated for the treatment of patients with CRC
that harbor somatic mutations in exon 2 (codons 12 and 13), exon 3
(codons 59 and 61), and exon 4 (codons 117 and 146) of either K-Ras
or N-Ras and hereafter referred to as "Ras" or when the Ras status
is unknown.
- Retrospective subset analyses of Ras-mutant and wild-type
populations across several randomized clinical trials, including
CRYSTAL, were conducted to investigate the role of Ras mutations on
the clinical effects of anti-EGFR-directed monoclonal antibodies.
Use of cetuximab in patients with Ras mutations resulted in no
clinical benefit with treatment related toxicity. Confirm Ras
mutation status in tumor specimens prior to initiating
ERBITUX.
Embryo-Fetal Toxicity
- Based on animal data and its mechanism of action, ERBITUX can
cause fetal harm when administered to a pregnant woman. There are
no available data for ERBITUX exposure in pregnant women. In an
animal reproduction study, intravenous administration of cetuximab
once weekly to pregnant cynomolgus monkeys during the period of
organogenesis resulted in an increased incidence of embryolethality
and abortion. Disruption or depletion of EGFR in animal models
results in impairment of embryo-fetal development including effects
on placental, lung, cardiac, skin, and neural development. Advise
pregnant women of the potential risk to a fetus. Advise females of
reproductive potential to use effective contraception during
treatment with ERBITUX and for 2 months after the last dose of
ERBITUX. Verify pregnancy status in females of reproductive
potential prior to initiating ERBITUX.
Adverse Reactions
- The most common adverse reactions in ERBITUX clinical trials
(incidence ≥25%) include cutaneous adverse reactions (including
rash, pruritus, and nail changes), headache, diarrhea, and
infection.
- The most common adverse reactions (all grades; incidence ≥25%)
seen in patients with carcinomas of the head and neck receiving
ERBITUX in combination with radiation therapy (n=208) versus
radiation alone (n=212) (BONNER) were acneiform rash (87% vs 10%),
radiation dermatitis (86% vs 90%), weight loss (84% vs 72%),
asthenia (56% vs 49%), nausea (49% vs 37%), increased alanine
transaminase (43% vs 21%), increased aspartate transaminase (38% vs
24%), increased alkaline phosphatase (33% vs 24%), fever (29% vs
13%), emesis (29% vs 23%), pharyngitis (26% vs 19%) and dehydration
(25% vs 19%). The most common grade 3 and 4 adverse reactions for
ERBITUX in combination with radiation therapy (≥10%) versus
radiation alone included: radiation dermatitis (23% vs 18%),
acneiform rash (17% vs 1%), and weight loss (11% vs 7%). The
overall incidence of late radiation toxicities (any grade) was
higher for patients receiving ERBITUX in combination with radiation
therapy, versus radiation therapy alone. The following sites were
affected: salivary glands (65% vs 56%), larynx (52% vs 36%),
subcutaneous tissue (49% vs 45%), mucous membrane (48% vs 39%),
esophagus (44% vs 35%), skin (42% vs 33%). The incidence of Grade 3
or 4 late radiation toxicities was similar between radiation
therapy alone and the ERBITUX with radiation treatment groups.
- The most common adverse reactions (all grades; incidence ≥25%)
seen in patients with carcinomas of the head and neck receiving a
cetuximab product in combination with platinum-based therapy and
fluorouracil (CT) (n=219) versus CT alone (n=215) (EXTREME) were
acneiform rash (70% vs 2%), nausea (54% vs 47%), infection (44% vs
27%), rash (28% vs 2%), diarrhea (26% vs 16%) and anorexia (25% vs
14%). The most common grade 3 and 4 adverse reactions for a
cetuximab product in combination with CT (≥10%) versus CT alone was
infection (11% vs 8%). Because ERBITUX provides approximately 22%
higher exposure relative to the cetuximab product used in EXTREME,
the data provided above may underestimate the incidence and
severity of adverse reactions anticipated with ERBITUX for this
indication. However, the tolerability of the recommended dose is
supported by safety data from additional studies of ERBITUX.
- The most common adverse reactions (all grades; incidence ≥25%)
seen in patients with K-Ras wild-type, EGFR-expressing mCRC treated
with a cetuximab product in combination with FOLFIRI (n=317) versus
FOLFIRI alone (n=350) (CRYSTAL) were acne-like rash (86% vs 13%),
diarrhea (66% vs 60%), neutropenia (49% vs 42%), rash (44% vs 4%),
stomatitis (31% vs 19%), anorexia (30% vs 23%), dermatitis
acneiform (26% vs <1%) and pyrexia (26% vs 14%). The most common
grade 3 and 4 adverse reactions (≥10%) included: neutropenia (31%
vs 24%), acne-like rash (18% vs <1%), and diarrhea (16% vs 10%).
ERBITUX provides approximately 22% higher exposure compared to the
cetuximab product used in CRYSTAL; however, the safety data from
CRYSTAL is consistent in incidence and severity of adverse
reactions with those seen for ERBITUX in this indication.
- The most common adverse reactions (all grades; incidence ≥25%)
seen in patients with K-Ras wild-type, EGFR-expressing mCRC treated
with ERBITUX + best supportive care (BSC) (n=118) versus BSC alone
(n=124) (CA225-025) were rash/desquamation (95% vs 21%), fatigue
(91% vs 79%), nausea (64% vs 50%), pain-other (59% vs 37%), dry
skin (57% vs 15%), constipation (53% vs 38%), dyspnea (49% vs 44%),
pruritis (47% vs 11%), neuropathy-sensory (45% vs 38%), diarrhea
(42% vs 23%), vomiting (40% vs 26%), headache (38% vs 11%),
infection without neutropenia (38% vs 19%), other-dermatology (35%
vs 7%), stomatitis (32% vs 10%), nail changes (31% vs 4%), cough
(30% vs 19%), insomnia (27% vs 13%) and fever (25% vs 16%). The
most common grade 3 and 4 adverse reactions (≥10%) included:
fatigue (31% vs 29%), pain-other (18% vs 10%), rash/desquamation
(16% vs 1%), dyspnea (16% vs 13%), other-gastrointestinal (12% vs
5%), and infection without neutropenia (11% vs 5%).
- The most common adverse reactions (all grades) seen in patients
with EGFR-expressing recurrent mCRC (n=354) treated with ERBITUX
plus irinotecan in clinical trials (CP02-9923 and BOND) were
acneiform rash (88%), asthenia/malaise (73%), diarrhea (72%), and
nausea (55%). The most common grade 3-4 adverse reactions included:
diarrhea (22%), leukopenia (17%), asthenia/malaise (16%), and
acneiform rash (14%)
Use in Specific Populations
- Lactation: There is no information regarding the
presence of ERBITUX in human milk, the effects on the breastfed
infant, or the effects on milk production. Human IgG antibodies can
be excreted in human milk. Because of the potential for serious
adverse reactions in nursing infants from ERBITUX, advise women not
to breastfeed during treatment with ERBITUX and for at least 2
months after the last dose of ERBITUX.
- Pediatric Use: The safety and effectiveness of ERBITUX
in pediatric patients have not been established. No new safety
signals were identified in pediatric patients when ERBITUX in
combination with irinotecan was administered in an open-label,
single-arm dose-finding study in 27 patients with refractory solid
tumors aged 1 to 12 years old and in 19 patients aged 13 to 18
years old.
- Geriatric Use: In mCRC clinical studies, no overall
differences in safety or efficacy of ERBITUX were observed between
patients >65 years of age and younger patients. In SCCHN
clinical studies of ERBITUX there were insufficient number of
patients >65 years of age to determine whether they respond
differently from younger patients.
CE HCP ISI_ALL 17NOV2020
Please see full U.S. Prescribing
Information for ERBITUX, including Boxed Warnings
regarding infusion reactions and cardiopulmonary arrest.
About Lilly Oncology
For more than 50 years, Lilly has been dedicated to delivering
life-changing medicines and support to people living with cancer
and those who care for them. Lilly is determined to build on this
heritage and continue making life better for all those affected by
cancer around the world. To learn more about Lilly's commitment to
people with cancer, please visit www.LillyOncology.com.
About Loxo Oncology at Lilly
Loxo Oncology at Lilly was created in December
2019, combining the Lilly Research Laboratories oncology
organization and Loxo Oncology, which was acquired
by Lilly in early 2019. Loxo
Oncology at Lilly brings together the focus and
spirit of a biotech with the scale and resources of large pharma,
with the goal of rapidly delivering impactful new medicines for
people with cancer. Our approach centers on creating new oncology
medicines that unequivocally work early in clinical development and
will matter to patients.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with
discovery to create medicines that make life better for people
around the world. We were founded more than a century ago by a man
committed to creating high-quality medicines that meet real needs,
and today we remain true to that mission in all our work. Across
the globe, Lilly employees work to discover and bring life-changing
medicines to those who need them, improve the understanding and
management of disease, and give back to communities through
philanthropy and volunteerism. To learn more about Lilly, please
visit us at lilly.com and lilly.com/newsroom. P-LLY
© Lilly USA, LLC 2021. ALL
RIGHTS RESERVED.
CYRAMZA ®, ERBITUX ®,
Retevmo® and Verzenio® are trademarks
owned by or licensed to Eli Lilly and Company, its subsidiaries, or
affiliates.
Fulvestrant (Faslodex®), MedImmune/AstraZeneca.
MedImmune Limited/AstraZeneca provided fulvestrant for the use in
clinical trials.
Lilly Forward-Looking Statement
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about Lilly's oncology portfolio and pipeline, including
Verzenio, Retevmo, CYRAMZA, ERBITUX and LY3484356, and reflects
Lilly's current beliefs and expectations. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of research, development, regulatory
approval, and commercialization. Among other things, there can be
no guarantee that future studies will be completed as planned, that
future study results will be consistent with the results to date,
that Verzenio, Retevmo, CYRAMZA, ERBITUX or LY3484356 will receive
(or receive additional) regulatory approvals or be commercially
successful. For further discussion of these and other risks and
uncertainties, see Lilly's most recent Form 10-K and Form 10-Q
filings with the United States Securities and Exchange Commission.
Except as required by law, Lilly undertakes no duty to update
forward-looking statements to reflect events after the date of this
release.
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1 RETEVMO [package
insert]. Indianapolis, IN: Eli Lilly and Company;
2021.
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Refer to:
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Courtney Kasinger;
ckasinger@lilly.com; 317-501-7056 (Media)
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Lauren Cohen;
lcohen@loxooncology.com; 617-678-2067 (Media)
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Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (Investors)
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SOURCE Eli Lilly and Company