THOUSAND OAKS, Calif.,
May 19, 2016 /PRNewswire/
-- Amgen (NASDAQ: AMGN) today announced it will present new
data from its oncology portfolio at the 21st Congress of
the European Hematology Association (EHA), June 9-12, 2016, in Copenhagen. Key data to be presented include
studies evaluating BLINCYTO® (blinatumomab),
Kyprolis® (carfilzomib), Aranesp®
(darbepoetin alfa) and Nplate® (romiplostim). Data from
the BLINCYTO TOWER study will be presented during the Presidential
Symposium on Friday, June 10, and is
recognized as a top abstract submitted to the Congress. This, along
with other presentations, reinforces Amgen's commitment to serve
patients with hematologic malignancies through the development of
innovative and novel products.
"We are excited that the data from the TOWER study, which is the
first randomized study of an immunotherapy to demonstrate overall
survival benefit in adult patients with Ph-negative relapsed or
refractory B-cell precursor acute lymphoblastic leukemia, will be
featured at the Presidential Symposium this year at EHA," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "This recognition
along with other key data being presented validates our ongoing
commitment to developing innovative therapies that have the
potential to tackle unmet needs in complex-to-treat patient
populations."
Key data include findings from clinical trials in acute
lymphoblastic leukemia (ALL), multiple myeloma (MM),
myelodysplastic syndrome (MDS) and immune thrombocytopenia
(ITP):
BLINCYTO data
BLINCYTO was granted conditional marketing authorization by the
European Commission (EC) last November and is the first bispecific
T cell engager (BiTE®) antibody construct approved in
the European Union (EU) for the treatment of adults with
Philadelphia chromosome-negative
(Ph-) relapsed or refractory B-cell precursor ALL. Data from the
comprehensive ALL development program to be presented will
include:
- Blinatumomab Improved Overall Survival in Patients with
Relapsed/Refractory Philadelphia Negative B-Cell Precursor Acute
Lymphoblastic Leukemia in a Randomized, Open-Label Phase 3 Study
(TOWER)
Abstract No. S149, Oral presentation, Presidential symposium,
Friday, June 10, 2016, 4:45 –
5 p.m. (CEST), Hall A1
ALL data
- Trends in the Use of Hematopoietic Stem Cell Transplantation
for Adults with Acute Lymphoblastic Leukemia (ALL): A Report From
the Acute Leukemia Working Party of the European Society for Blood
and Marrow Transplantation (EBMT)
Abstract No. S524, Oral presentation, Stem cell transplantation -
Clinical 1, Saturday, June 11, 2016,
4:45 – 5 p.m. (CEST), Room H5
Kyprolis data
Kyprolis was granted marketing authorization by the EC last
November for use in combination treatment of patients with relapsed
multiple myeloma. Data to be presented include:
- Carfilzomib, Lenalidomide, and Dexamethasone vs.
Lenalidomide and Dexamethasone in Patients with Relapsed Multiple
Myeloma: Analysis of Response and Progression-Free Survival Hazard
Ratio Over Time
Abstract No. P275, Poster presentation,
Innovative therapies for MM 1, Friday, June 10, 2016 , 5:15 –
6:45 p.m. (CEST), Poster area (Hall
H)
- Outcomes for Asian Patients with Relapsed Multiple Myeloma
Treated with Carfilzomib and Dexamethasone vs. Bortezomib and
Dexamethasone: A Subgroup Analysis of the Phase 3 ENDEAVOR Study
(NCT01568866)
Abstract No. E1328, Eposter presentation,
Myeloma and other monoclonal gammopathies – Clinical
- Carfilzomib and Dexamethasone vs. Subcutaneous Bortezomib
and Dexamethasone in Patients with Relapsed or Refractory Multiple
Myeloma: Secondary Analysis from the Phase 3 Study ENDEAVOR
(NCT01568866)
Abstract No. P659, Poster presentation,
Innovative therapies for MM 4 Saturday, June 11, 2016, 5:30 – 7 p.m. (CEST), Poster area (Hall H)
- Efficacy and Safety by Cytogenetic Risk Status: Phase 3
Study (ASPIRE) of Carfilzomib, Lenalidomide and Dexamethasone
Versus Lenalidomide and Dexamethasone in Patients with Relapsed
Multiple Myeloma
Abstract No. P663, Poster presentation,
Innovative therapies for MM 4, Saturday, June 11, 2016, 5:30
– 7 p.m. (CEST), Poster area (Hall
H)
- A Sub-Study of the Phase 3 ENDEAVOR Study: Serial
Echocardiographic Assessment of Patients with Relapsed Multiple
Myeloma (RMM) Receiving Carfilzomib Plus Dexamethasone or
Bortezomib Plus Dexamethasone
Abstract No. P664, Poster
presentation, Innovative therapies for MM 4, Saturday, June
11, 2016, 5:30 – 7 p.m. (CEST),
Poster area (Hall H)
- Carfilzomib and Dexamethasone vs. Bortezomib and
Dexamethasone: Subgroup Analysis of Patients with Relapsed Multiple
Myeloma by Baseline Cytogenetic Risk Status (Phase 3 ENDEAVOR
Study)
Abstract No. E1267, Eposter presentation, Myeloma and
other monoclonal gammopathies - Clinical
- Carfilzomib and Dexamethasone vs. Bortezomib and
Dexamethasone in Patients with Relapsed Multiple Myeloma: Analysis
of the Phase 3 ENDEAVOR Study by Age Subgroup
Abstract No.
E1274, Eposter presentation, Myeloma and other monoclonal
gammopathies - Clinical
- Carfilzomib and Dexamethasone vs. Bortezomib and
Dexamethasone: Subgroup Analysis of the Phase 3 ENDEAVOR Study to
Evaluate the Impact of Prior Treatment on Patients with Relapsed
Multiple Myeloma
Abstract No. E1266, Eposter presentation,
Myeloma and other monoclonal gammopathies - Clinical
- Weekly Carfilzomib with Dexamethasone for Patients with
Relapsed or Refractory Multiple Myeloma: Updated Results from the
Phase 1/2 Study CHAMPION-1 (NCT01677858)
Abstract No. P661,
Poster presentation, Innovative therapies for MM 4, Saturday, June 11, 2016, 5:30 – 7 p.m. (CEST), Poster area (Hall H)
- The Effect of Level of Response to Treatment on Associated
Costs and Healthcare Resource Utilization: A Retrospective Chart
Review Study in Patients with Symptomatic Multiple
Myeloma
Abstract No. E1310, Eposter presentation, Myeloma
and other monoclonal gammopathies - Clinical
- Survival and Treatment Patterns in Patients with Symptomatic
Multiple Myeloma (MM) in A Real-World Setting
Abstract No.
E1280, Eposter presentation, Myeloma and other monoclonal
gammopathies - Clinical
- Description of Patient Characteristics, Treatment Patterns
and Resource Use for Patients with Multiple Myeloma Treated in
Three Local Health Units (LHUS) in Italy
Abstract No. E1327, Eposter
presentation, Myeloma and other monoclonal gammopathies -
Clinical
- Overall Survival in Patients with Symptomatic Multiple
Myeloma in the Real-World Setting: A Retrospective Analysis of the
Pharos Registry in the
Netherlands
Abstract No. E1292, Eposter presentation,
Myeloma and other monoclonal gammopathies - Clinical
Aranesp data
Aranesp received initial EU approval within oncology in
August 2002 and is indicated for the
treatment of symptomatic anemia in adult cancer patients with
non-myeloid malignancies receiving chemotherapy. Data to be
presented include:
- ARCADE (20090160): A Phase 3 Randomized Placebo-Controlled
Double-Blind Trial of Darbepoetin Alfa in the Treatment Of Anemia
in Patients with Low or Intermediate-1 Risk Myelodysplastic
Syndromes (MDS)
Abstract No.S128, Oral presentation, Myelodysplastic syndromes –
Clinical, Friday, June 10, 2016,
11:30 – 11:45 a.m. (CEST), Hall
C14
Nplate data
Nplate, a thrombopoietin receptor agonist, was approved in the
EU in February 2009 for the treatment
of adult chronic-immune (idiopathic)-thrombocytopenic-purpura (ITP)
patients who are refractory to other treatments (e.g.
corticosteroids, immunoglobulins). Data to be presented
include:
- Romiplostim in Splenectomized (Splnx) and Nonsplenectomized
(Nonsplnx) Patients with Immune Thrombocytopenia (ITP)
Abstract No. S520, Oral presentation, Platelet disorders 1,
Saturday, June 11, 2016, 5 –
5:15 p.m. (CEST), Room H4
- Characterization of Patients with Immune Thrombocytopenia
(ITP) Entering Remission in a Romiplostim Bone Marrow Study
Abstract No. P405, Poster presentation, Platelet disorders,
Friday, June 10, 2016, 5:15 –
6:45 p.m. (CEST), Poster area (Hall
H)
- Safety and Efficacy of Long-Term Open-Label Dosing of
Subcutaneous (SC) Romiplostim in Children with Immune
Thrombocytopenia (ITP)
Abstract No. E1416, Eposter presentation, Platelet disorders
- Primary Immune Thrombocytopenia Treated with Romiplostim in
Routine Clinical Practice: A Retrospective Study from the United
Kingdom Immune Thrombocytopenia Registry
Abstract No. E1426, Eposter presentation, Platelets disorders
- Romiplostim in Children with Immune Thrombocytopenia: A
Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
Abstract No. P401, Poster presentation, Platelet disorders,
Friday, June 10, 2016, 5:15 –
6:45 p.m. (CEST), Poster area (Hall
H)
- Safety and Efficacy/Effectiveness of Second-Line Treatments
in Patients with Immune Thrombocytopenia: A Systematic Review of
the Literature
Abstract No. E1417, Eposter presentation, Platelets disorders
Abstracts are available and can be viewed on the EHA website at
http://learningcenter.ehaweb.org/eha/#!*menu=16*browseby=2*sortby=1*media=3*label=9759.
About BLINCYTO® (blinatumomab)
BLINCYTO is a bispecific CD19-directed CD3 T cell engager
(BiTE®) antibody construct that binds specifically to
CD19 expressed on the surface of cells of B-lineage origin and CD3
expressed on the surface of T cells.
BLINCYTO was granted breakthrough therapy and priority review
designations by the U.S. Food and Drug Administration, and is now
approved in the U.S. for the treatment of Ph- relapsed or
refractory B-cell precursor ALL. This indication is approved under
accelerated approval. Continued approval for this indication may be
contingent upon verification of clinical benefit in subsequent
trials.
In November 2015, BLINCYTO was
granted conditional marketing authorization in the European Union
for the treatment of adults with Ph- relapsed or refractory B-cell
precursor ALL.
Important EU BLINCYTO®
(blinatumomab) Safety Information
This product is subject to additional monitoring in the EU.
All suspected adverse reactions should be reported in accordance
with the national reporting system.
The adverse reactions described in this section were identified
in the pivotal clinical study (N=189).The most serious adverse
reactions that may occur during blinatumomab treatment include:
infections (31.7%), neurologic events (16.4%), neutropenia/febrile
neutropenia (15.3%), cytokine release syndrome (0.5%), and tumor
lysis syndrome (0.5%). The most common adverse reactions were:
infusion-related reactions (67.2%), infections (63.0%), pyrexia
(59.8%), headache (34.4%), febrile neutropenia (28%), peripheral
edema (25.9%), nausea (24.3%), hypokalaemia (23.8%), constipation
(20.6%), anaemia (20.1%), cough (18.5%), diarrhea (18.0%), tremor
(17.5%), neutropenia (17.5%), abdominal pain (16.9%), insomnia
(15.3%), fatigue (15.3%), and chills (15.3%).
Please refer to the Summary of Product Characteristics for
full European prescribing information.
Important Safety Information Regarding
BLINCYTO® (blinatumomab) U.S. Indication
This safety information is specific to the current U.S. approved
indication.
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL
TOXICITIES
- Cytokine Release Syndrome (CRS), which may be
life-threatening or fatal, occurred in patients receiving
BLINCYTO®. Interrupt or discontinue
BLINCYTO® as recommended.
- Neurological toxicities, which may be severe,
life-threatening or fatal, occurred in patients receiving
BLINCYTO®. Interrupt or discontinue
BLINCYTO® as recommended.
Contraindications
BLINCYTO® is contraindicated in patients with a
known hypersensitivity to blinatumomab or to any component of the
product formulation.
Warnings and Precautions
Cytokine Release Syndrome (CRS): Life-threatening or
fatal CRS occurred in patients receiving BLINCYTO®.
Infusion reactions have occurred and may be clinically
indistinguishable from manifestations of CRS. Closely monitor
patients for signs and symptoms of serious events such as pyrexia,
headache, nausea, asthenia, hypotension, increased alanine
aminotransferase (ALT), increased aspartate aminotransferase (AST),
increased total bilirubin (TBILI), disseminated intravascular
coagulation (DIC), capillary leak syndrome (CLS), and
hemophagocytic lymphohistiocytosis/macrophage activation syndrome
(HLH/MAS). Interrupt or discontinue BLINCYTO® as
outlined in the Prescribing Information (PI).
Neurological Toxicities: Approximately 50% of patients
receiving BLINCYTO® in clinical trials experienced
neurological toxicities. Severe, life-threatening, or fatal
neurological toxicities occurred in approximately 15% of patients,
including encephalopathy, convulsions, speech disorders,
disturbances in consciousness, confusion and disorientation, and
coordination and balance disorders. The median time to onset of any
neurological toxicity was 7 days. Monitor patients for signs or
symptoms and interrupt or discontinue BLINCYTO® as
outlined in the PI.
Infections: Approximately 25% of patients receiving
BLINCYTO® experienced serious infections, some of which
were life-threatening or fatal. Administer prophylactic antibiotics
and employ surveillance testing as appropriate during treatment.
Monitor patients for signs or symptoms of infection and treat
appropriately, including interruption or discontinuation of
BLINCYTO® as needed.
Tumor Lysis Syndrome (TLS): Life-threatening or fatal TLS
has been observed. Preventive measures, including pretreatment
nontoxic cytoreduction and on treatment hydration, should be used
during BLINCYTO® treatment. Monitor patients for signs
and symptoms of TLS and interrupt or discontinue
BLINCYTO® as needed to manage these events.
Neutropenia and Febrile Neutropenia, including
life-threatening cases, have been observed. Monitor appropriate
laboratory parameters during BLINCYTO® infusion and
interrupt BLINCYTO® if prolonged neutropenia occurs.
Effects on Ability to Drive and Use Machines: Due to the
possibility of neurological events, including seizures, patients
receiving BLINCYTO® are at risk for loss of
consciousness, and should be advised against driving and engaging
in hazardous occupations or activities such as operating heavy or
potentially dangerous machinery while BLINCYTO® is being
administered.
Elevated Liver Enzymes: Transient elevations in liver
enzymes have been associated with BLINCYTO® treatment.
The majority of these events were observed in the setting of CRS.
The median time to onset was 15 days. Grade 3 or greater elevations
in liver enzymes occurred in 6% of patients outside the setting of
CRS and resulted in treatment discontinuation in less than 1% of
patients. Monitor ALT, AST, gamma-glutamyl transferase (GGT), and
TBILI prior to the start of and during BLINCYTO®
treatment. BLINCYTO® treatment should be interrupted if
transaminases rise to > 5 times the upper limit of normal (ULN)
or if TBILI rises to > 3 times ULN.
Leukoencephalopathy: Although the clinical significance
is unknown, cranial magnetic resonance imaging (MRI) changes
showing leukoencephalopathy have been observed in patients
receiving BLINCYTO® especially in patients previously
treated with cranial irradiation and anti-leukemic chemotherapy.
Preparation and administration errors have occurred with
BLINCYTO® treatment. Follow instructions for preparation
(including admixing) and administration in the PI strictly to
minimize medication errors (including underdose and overdose).
Adverse Reactions
The most commonly reported adverse reactions (≥ 20%) in clinical
trials were pyrexia (62%), headache (36%), peripheral edema (25%),
febrile neutropenia (25%), nausea (25%), hypokalemia (23%), rash
(21%), tremor (20%), diarrhea (20%) and constipation (20%).
Serious adverse reactions were reported in 65% of patients. The
most common serious adverse reactions (≥ 2%) included febrile
neutropenia, pyrexia, pneumonia, sepsis, neutropenia,
device-related infection, tremor, encephalopathy, infection,
overdose, confusion, Staphylococcal bacteremia, and headache.
U.S. Dosage and Administration Guidelines
BLINCYTO® is administered as a continuous intravenous
infusion at a constant flow rate using an infusion pump which
should be programmable, lockable, non-elastomeric, and have an
alarm. It is very important that the instructions for
preparation (including admixing) and administration provided in the
full Prescribing Information are strictly followed to minimize
medication errors (including underdose and overdose).
Please see full U.S. Prescribing Information and medication
guide for BLINCYTO® at www.BLINCYTO.com.
About Kyprolis® (carfilzomib)
Proteasomes play an important role in cell function and growth
by breaking down proteins that are damaged or no longer
needed.1 Kyprolis has been shown to block
proteasomes, leading to an excessive build-up of proteins within
cells.2 In some cells, Kyprolis can cause cell
death, especially in myeloma cells because they are more likely to
contain a higher amount of abnormal proteins.2 The
irreversibility of Kyprolis' binding has also been shown to offer a
more sustained inhibition of the targeted enzymes.3
Kyprolis is approved in the United
States, Argentina,
Israel, Kuwait, Mexico, Thailand, Colombia, Korea, Canada and the European Union. Additional
regulatory applications for Kyprolis are underway and have been
submitted to health authorities worldwide.
Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx
Pharmaceuticals is a subsidiary of Amgen and holds development and
commercialization rights to Kyprolis globally, excluding
Japan. For more information,
please visit www.kyprolis.com.
Important EU
Kyprolis® (carfilzomib) Safety
Information
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions.
Kyprolis treatment should be supervised by a physician
experienced in the use of anti-cancer therapy. The most serious
side effects that may occur during Kyprolis treatment include:
Cardiac toxicity, pulmonary toxicities, pulmonary hypertension,
dyspnea, hypertension including hypertensive crises, acute renal
failure, tumor lysis syndrome, infusion reactions,
thrombocytopenia, hepatic toxicity, posterior reversible
encephalopathy syndrome (PRES) and thrombotic thrombocytopenic
purpura/hemolytic uremic syndrome (TTP/HUS). The most common side
effects are anemia, fatigue, diarrhea, thrombocytopenia, nausea,
pyrexia, dyspnea, respiratory tract infection, cough and peripheral
edema.
Please refer to the Summary of Product Characteristics for
full European prescribing information.
Important U.S. Safety Information Regarding
Kyprolis® (carfilzomib) for
Injection
INDICATION(S)
- KYPROLIS® (carfilzomib) is indicated in
combination with dexamethasone or with lenalidomide plus
dexamethasone for the treatment of patients with relapsed or
refractory multiple myeloma who have received one to three lines of
therapy.
- KYPROLIS® (carfilzomib) is indicated as a single
agent for the treatment of patients with relapsed or refractory
multiple myeloma who have received one or more lines of
therapy.
IMPORTANT SAFETY INFORMATION
Cardiac Toxicities
- New onset or worsening of pre-existing cardiac failure (e.g.,
congestive heart failure, pulmonary edema, decreased ejection
fraction), restrictive cardiomyopathy, myocardial ischemia, and
myocardial infarction including fatalities have occurred following
administration of KYPROLIS. Some events occurred in patients with
normal baseline ventricular function. Death due to cardiac arrest
has occurred within one day of KYPROLIS administration.
- Monitor patients for clinical signs or symptoms of cardiac
failure or cardiac ischemia. Evaluate promptly if cardiac toxicity
is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse
events until recovery, and consider whether to restart KYPROLIS at
1 dose level reduction based on a benefit/risk assessment.
- While adequate hydration is required prior to each dose in
Cycle 1, monitor all patients for evidence of volume overload,
especially patients at risk for cardiac failure. Adjust total fluid
intake as clinically appropriate in patients with baseline cardiac
failure or who are at risk for cardiac failure.
- Patients ≥ 75 years, the risk of cardiac failure is increased.
Patients with New York Heart Association Class III and IV heart
failure, recent myocardial infarction, conduction abnormalities,
angina, or arrhythmias may be at greater risk for cardiac
complications and should have a comprehensive medical assessment
(including blood pressure and fluid management) prior to starting
treatment with KYPROLIS and remain under close follow-up.
Acute Renal Failure
- Cases of acute renal failure and renal insufficiency adverse
events (including renal failure) have occurred in patients
receiving KYPROLIS. Acute renal failure was reported more
frequently in patients with advanced relapsed and refractory
multiple myeloma who received KYPROLIS monotherapy. Monitor renal
function with regular measurement of the serum creatinine and/or
estimated creatinine clearance. Reduce or withhold dose as
appropriate.
Tumor Lysis Syndrome
- Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes,
have occurred in patients receiving KYPROLIS. Patients with
multiple myeloma and a high tumor burden should be considered at
greater risk for TLS. Adequate hydration is required prior to each
dose in Cycle 1, and in subsequent cycles as needed. Consider uric
acid lowering drugs in patients at risk for TLS. Monitor for
evidence of TLS during treatment and manage promptly. Withhold
KYPROLIS until TLS is resolved.
Pulmonary Toxicity
- Acute Respiratory Distress Syndrome (ARDS), acute respiratory
failure, and acute diffuse infiltrative pulmonary disease such as
pneumonitis and interstitial lung disease have occurred in patients
receiving KYPROLIS. Some events have been fatal. In the event of
drug‐induced pulmonary toxicity, discontinue KYPROLIS.
Pulmonary Hypertension
- Pulmonary arterial hypertension (PAH) was reported in patients
treated with KYPROLIS. Evaluate with cardiac imaging and/or other
tests as indicated. Withhold KYPROLIS for PAH until resolved or
returned to baseline and consider whether to restart KYPROLIS based
on a benefit/risk assessment.
Dyspnea
- Dyspnea was reported in patients treated with KYPROLIS.
Evaluate dyspnea to exclude cardiopulmonary conditions including
cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3
or 4 dyspnea until resolved or returned to baseline. Consider
whether to restart KYPROLIS based on a benefit/risk
assessment.
Hypertension
- Hypertension, including hypertensive crisis and hypertensive
emergency, has been observed with KYPROLIS. Some of these events
have been fatal. Monitor blood pressure regularly in all patients.
If hypertension cannot be adequately controlled, withhold KYPROLIS
and evaluate. Consider whether to restart KYPROLIS based on a
benefit/risk assessment.
Venous Thrombosis
- Venous thromboembolic events (including deep venous thrombosis
and pulmonary embolism) have been observed with KYPROLIS.
Thromboprophylaxis is recommended for patients being treated with
the combination of KYPROLIS with dexamethasone or with lenalidomide
plus dexamethasone. The thromboprophylaxis regimen should be based
on an assessment of the patient's underlying risks.
- Patients using oral contraceptives or a hormonal method of
contraception associated with a risk of thrombosis should consider
an alternative method of effective contraception during treatment
with KYPROLIS in combination with dexamethasone or lenalidomide
plus dexamethasone.
Infusion Reactions
- Infusion reactions, including life‐threatening reactions, have
occurred in patients receiving KYPROLIS. Symptoms include fever,
chills, arthralgia, myalgia, facial flushing, facial edema,
vomiting, weakness, shortness of breath, hypotension, syncope,
chest tightness, or angina. These reactions can occur immediately
following or up to 24 hours after administration of KYPROLIS.
Premedicate with dexamethasone to reduce the incidence and severity
of infusion reactions. Inform patients of the risk and of symptoms
of an infusion reaction and to contact a physician immediately if
they occur.
Thrombocytopenia
- KYPROLIS causes thrombocytopenia with recovery to baseline
platelet count usually by the start of the next cycle.
Thrombocytopenia was reported in patients receiving KYPROLIS.
Monitor platelet counts frequently during treatment with KYPROLIS.
Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure
- Cases of hepatic failure, including fatal cases, have been
reported during treatment with KYPROLIS. KYPROLIS can cause
increased serum transaminases. Monitor liver enzymes regularly
regardless of baseline values. Reduce or withhold dose as
appropriate.
Thrombotic Microangiopathy
- Cases of thrombotic microangiopathy, including thrombotic
thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS),
including fatal outcome have occurred in patients receiving
KYPROLIS. Monitor for signs and symptoms of TTP/HUS. Discontinue
KYPROLIS if diagnosis is suspected. If the diagnosis of TTP/HUS is
excluded, KYPROLIS may be restarted. The safety of reinitiating
KYPROLIS therapy in patients previously experiencing TTP/HUS is not
known.
Posterior Reversible Encephalopathy Syndrome (PRES)
- Cases of PRES have occurred in patients receiving KYPROLIS.
PRES was formerly known as Reversible Posterior Leukoencephalopathy
Syndrome. Consider a neuro‐radiological imaging (MRI) for onset of
visual or neurological symptoms. Discontinue KYPROLIS if PRES is
suspected and evaluate. The safety of reinitiating KYPROLIS therapy
in patients previously experiencing PRES is not known.
Embryo-fetal Toxicity
- KYPROLIS can cause fetal harm when administered to a pregnant
woman based on its mechanism of action and findings in
animals.
- Females of reproductive potential should be advised to avoid
becoming pregnant while being treated with KYPROLIS. Males of
reproductive potential should be advised to avoid fathering a child
while being treated with KYPROLIS. If this drug is used during
pregnancy, or if pregnancy occurs while taking this drug, the
patient should be apprised of the potential hazard to the
fetus.
ADVERSE REACTIONS
- The most common adverse events occurring in at least 20% of
patients treated with KYPROLIS in the combination therapy trials:
anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia,
pyrexia, insomnia, muscle spasm, cough, upper respiratory tract
infection, hypokalemia.
- The most common adverse events occurring in at least 20% of
patients treated with KYPROLIS in monotherapy trials: anemia,
fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea,
headache, cough, edema peripheral.
Please see full Prescribing Information
at www.kyprolis.com.
About Aranesp® (darbepoetin alfa) in
the U.S.
Aranesp is indicated for the treatment of anemia due to
chronic kidney disease (CKD), including patients on dialysis and
patients not on dialysis.
Aranesp is indicated for the treatment of anemia in
patients with non-myeloid malignancies where anemia is due to the
effect of concomitant myelosuppressive chemotherapy, and upon
initiation, there is a minimum of two additional months of planned
chemotherapy.
Limitations of Use:
Aranesp has not been shown to improve quality of life,
fatigue, or patient well-being.
Aranesp is not indicated for use:
- In patients with cancer receiving hormonal agents, biologic
products, or radiotherapy, unless also receiving concomitant
myelosuppressive chemotherapy.
- In patients with cancer receiving myelosuppressive chemotherapy
when the anticipated outcome is cure.
- As a substitute for red blood cell transfusions in patients who
require immediate correction of anemia.
Important EU Aranesp® Safety Information
Aranesp is indicated for treatment of symptomatic anemia in
adult cancer patients with non-myeloid malignancies receiving
chemotherapy.
Aranesp is contraindicated in patients with poorly controlled
hypertension.
As with all growth factors, there is a concern that epoetins
could stimulate the growth of tumours. In several controlled
studies, epoetins have not been shown to improve overall survival
or decrease the risk of tumour progression in patients with anemia
associated with cancer.
In controlled clinical studies, use of Aranesp and other ESAs
have shown:
- Shortened time to tumour progression in patients with advanced
head and neck cancer receiving radiation therapy when administered
to target Hb > 14 g/dL; ESAs are not indicated for use in this
patient population
- Shortened overall survival and increased deaths attributed to
disease progression at 4 months in patients with metastatic breast
cancer receiving chemotherapy when administered to target Hb 12-14
g/dL(7.5-8.7 mmol/l).
- Increased risk of death when administered to target Hb of 12
g/dl (7.5 mmol/l) in patients with active malignant disease
receiving neither chemotherapy nor radiation therapy; ESAs are not
indicated for use in this patient population.
In view of the above, in some clinical situations blood
transfusion should be the preferred treatment for the management of
anemia in patients with cancer. The decision to administer
recombinant erythropoietins should be based on a benefit-risk
assessment with the participation of the individual patient, which
should take into account the specific clinical context. Factors
that should be considered in this assessment should include the
type of tumour and its stage; the degree of anemia;
life-expectancy; the environment in which the patient is being
treated; and patient preference.
In patients with solid tumours or lymphoproliferative
malignancies, if Hb >12 g/dL (7.5 mmol/l), the dose should be
reduced according to the instructions provided in the Summary of
Product Characteristics to minimise the potential risk of
thromboembolic events. Platelet counts and haemoglobin level should
also be monitored at regular intervals.
Discontinue use after the end of chemotherapy.
Please refer to the Summary of Product Characteristics for
full European prescribing information.
Important U.S. Safety Information for
Aranesp®(darbepoetin alfa)
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL
INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR
ACCESS AND TUMOR PROGRESSION OR RECURRENCE
Chronic Kidney Disease:
- In controlled trials, patients experienced greater risks for
death, serious adverse cardiovascular reactions, and stroke when
administered erythropoiesis-stimulating agents (ESAs) to target a
hemoglobin level of greater than 11 g/dL.
- No trial has identified a hemoglobin target level,
Aranesp® dose, or dosing strategy
that does not increase these risks.
- Use the lowest Aranesp® dose
sufficient to reduce the need for red blood cell (RBC)
transfusions.
Cancer:
- ESAs shortened overall survival and/or increased the risk of
tumor progression or recurrence in clinical studies of patients
with breast, non-small cell lung, head and neck, lymphoid, and
cervical cancers.
- Because of these risks, prescribers and hospitals must
enroll in and comply with the ESA APPRISE Oncology Program to
prescribe and/or dispense Aranesp® to
patients with cancer. To enroll in the ESA APPRISE Oncology
Program, visit www.esa-apprise.com or call
1-866-284-8089 for further assistance.
- To decrease these risks, as well as the risk of serious
cardiovascular and thromboembolic reactions, use the lowest dose
needed to avoid RBC transfusions.
- Use ESAs only for anemia from myelosuppressive
chemotherapy.
- ESAs are not indicated for patients receiving
myelosuppressive chemotherapy when the anticipated outcome is
cure.
- Discontinue following the completion of a chemotherapy
course.
Aranesp is contraindicated in patients with uncontrolled
hypertension, pure red cell aplasia (PRCA) that begins after
treatment with Aranesp or other erythropoietin protein drugs,
or serious allergic reactions to Aranesp.
Use caution in patients with CKD and coexistent cardiovascular
disease and stroke. Patients with CKD and an insufficient
hemoglobin response to ESA therapy may be at even greater risk for
cardiovascular reactions and mortality than other patients. A rate
of hemoglobin rise of > 1 g/dL over 2 weeks may contribute
to these risks. In controlled clinical trials of patients
with cancer, Aranesp and other ESAs increased the risks for
death and serious adverse cardiovascular reactions. These adverse
reactions included myocardial infarction and stroke. In controlled
clinical trials, ESAs increased the risk of death in patients
undergoing coronary artery bypass graft surgery (CABG) and the risk
of deep venous thrombosis (DVT) in patients undergoing orthopedic
procedures. Control hypertension prior to initiating and
during treatment with Aranesp.
Aranesp increases the risk of seizures in patients with
CKD. Monitor patients closely for new-onset seizures, premonitory
symptoms, or change in seizure frequency.
For lack or loss of hemoglobin response to Aranesp, initiate a
search for causative factors. If typical causes of lack or loss of
hemoglobin response are excluded, evaluate for PRCA. Cases of
PRCA and of severe anemia, with or without other cytopenias that
arise following the development of neutralizing antibodies to
erythropoietin have been reported in patients treated with Aranesp.
This has been reported predominantly in patients with CKD
receiving ESAs by subcutaneous administration. PRCA has also been
reported in patients receiving ESAs for anemia related to hepatitis
C treatment (an indication for which Aranesp is not approved).
If severe anemia and low reticulocyte count develop during
treatment with Aranesp, withhold Aranesp and
evaluate patients for neutralizing antibodies to erythropoietin.
Permanently discontinue Aranesp in patients who develop PRCA
following treatment with Aranesp or other erythropoietin
protein drugs. Do not switch patients to other ESAs.
Serious allergic reactions, including anaphylactic reactions,
angioedema, bronchospasm, skin rash, and urticaria may occur with
Aranesp. Immediately and permanently discontinue
Aranesp® if a serious allergic reaction occurs.
Adverse reactions (≥ 10%) in Aranesp clinical studies in
patients with CKD were hypertension, dyspnea, peripheral edema,
cough, and procedural hypotension. Adverse reactions (≥ 1%)
in Aranesp® clinical studies in cancer patients
receiving chemotherapy were abdominal pain, edema, and
thrombovascular events.
To see the Aranesp Prescribing Information, including Boxed
Warnings, and Medication Guide visit www.aranesp.com.
About Nplate® (romiplostim)
Nplate is approved in over 50 countries worldwide, including the
U.S., European Union (EU), Canada,
Australia, Russia, Mexico, Switzerland, Lichtenstein, Japan, Argentina, Israel, South
Korea, Hong Kong, and
Chile. Nplate also has received
orphan designation for chronic ITP in the U.S. (2003), the EU
(2005) and other parts of the world.
Nplate is the first FDA-approved treatment specifically for
adult chronic ITP
In the U.S., Nplate is indicated for the treatment of
thrombocytopenia in patients with chronic ITP who have had an
insufficient response to corticosteroids, immunoglobulins or
splenectomy. Nplate is not indicated for the treatment of
thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause
of thrombocytopenia other than chronic ITP. Nplate should be
used only in patients with ITP whose degree of thrombocytopenia and
clinical condition increase the risk for bleeding. Nplate should
not be used in an attempt to normalize platelet counts.
In the EU, Nplate is indicated for adult chronic-immune
(idiopathic)-thrombocytopenic-purpura (ITP) patients who are
refractory to other treatments (e.g. corticosteroids,
immunoglobulins).
Nplate was named as a recipient of the U.S. Prix Galien 2009
"Best Biotechnology Product" award and also received the 2009 Scrip
Awards for "Best New Drug." Nplate has also been honored with
numerous awards throughout the EU, including a 2010 Prix Galien in
France in the category of "Drugs
for Rare Diseases," and the 2011 Prix Galien in Germany in the category of "Specialist Care."
In September 2010, Nplate was awarded
the 2010 International Prix Galien Award, an award granted every
two years which recognizes the "best of the best" selected from
previous national Prix Galien award
recipients.
For more information about Nplate, please visit
www.Nplate.com.
Important EU Nplate® Safety Information
The EU Summary of Product Characteristics for Nplate lists the
following Special Warnings and Precautions: Reoccurrence of
thrombocytopenia and bleeding after cessation of treatment,
increased bone marrow reticulin, thrombotic/thromboembolic
complications, progression of existing MDS (in patients with MDS),
medication errors, loss of response to Nplate, and effects on red
and white blood cells.
The most common adverse reactions observed include
hypersensitivity reactions (including cases of rash, urticarial and
angioedema) and headache. As with all therapeutic proteins, there
is a potential for immunogenicity.
Please refer to the Summary of Product Characteristics for
full European prescribing information.
Important U.S. Nplate® Safety Information
Risk of Progression of Myelodysplastic Syndromes to Acute
Myelogenous Leukemia
- In Nplate® clinical trials of patients with
myelodysplastic syndromes (MDS) and severe thrombocytopenia,
progression from MDS to acute myelogenous leukemia (AML) has been
observed.
- Nplate® is not indicated for the treatment of
thrombocytopenia due to MDS or any cause of thrombocytopenia other
than chronic ITP.
Thrombotic/Thromboembolic Complications
- Thrombotic/thromboembolic complications may result from
increases in platelet counts with Nplate® use. Portal
vein thrombosis has been reported in patients with chronic liver
disease receiving Nplate®.
- To minimize the risk for thrombotic/thromboembolic
complications, do not use Nplate® in an attempt to
normalize platelet counts. Follow the dose adjustment guidelines to
achieve and maintain a platelet count of ≥ 50 x
109/L.
Loss of Response to Nplate®
- Hyporesponsiveness or failure to maintain a platelet response
with Nplate® should prompt a search for causative factors,
including neutralizing antibodies to Nplate®.
- To detect antibody formation, submit blood samples to Amgen
(1-800-772-6436). Amgen will assay these samples for antibodies to
Nplate® and thrombopoietin (TPO).
- Discontinue Nplate® if the platelet count does not
increase to a level sufficient to avoid clinically important
bleeding after 4 weeks at the highest weekly dose of 10
mcg/kg.
Laboratory Monitoring
- Obtain CBCs, including platelet counts, weekly during the dose
adjustment phase of
- Nplate® therapy and then monthly following
establishment of a stable Nplate® dose.
- Obtain CBCs, including platelet counts, weekly for at least two
weeks following discontinuation of Nplate®.
Adverse Reactions
- In the placebo-controlled trials, headache was the most
commonly reported adverse drug reaction, occurring in 35% of
patients receiving Nplate® and 32% of patients
receiving placebo. Headaches were usually of mild or moderate
severity.
- Most common adverse reactions (≥ 5% higher patient incidence in
Nplate® versus placebo) were Arthralgia (26%,
20%), Dizziness (17%, 0%), Insomnia (16%, 7%), Myalgia (14%, 2%),
Pain in Extremity (13%, 5%) , Abdominal Pain (11%, 0%), Shoulder
Pain (8%, 0%), Dyspepsia (7%, 0%), and Paresthesia (6%, 0%).
- Nplate® administration may increase the risk
for development or progression of reticulin fiber formation within
the bone marrow. This formation may improve upon discontinuation of
Nplate®. In a clinical trial, one patient with
ITP and hemolytic anemia developed marrow fibrosis with collagen
during Nplate® therapy.
Please see full U.S. Prescribing Information and
Medication Guide at www.Nplate.com
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
About Amgen's Commitment to Oncology
Amgen Oncology is committed to helping patients take on some of
the toughest cancers, such as those that have been resistant to
drugs, those that progress rapidly through the body and those where
limited treatment options exist. Amgen's supportive care treatments
help patients combat certain side effects of strong chemotherapy,
and our targeted medicines and immunotherapies focus on more than a
dozen different malignancies, ranging from blood cancers to solid
tumors. With decades of experience providing therapies for cancer
patients, Amgen continues to grow its portfolio of innovative and
biosimilar oncology medicines.
Forward-Looking Statements
This news release contains forward-looking statements that are
based on the current expectations and beliefs of Amgen. All
statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements,
including estimates of revenues, operating margins, capital
expenditures, cash, other financial metrics, expected legal,
arbitration, political, regulatory or clinical results or
practices, customer and prescriber patterns or practices,
reimbursement activities and outcomes and other such estimates and
results. Forward-looking statements involve significant risks and
uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission reports filed
by Amgen, including our most recent annual report on Form 10-K and
any subsequent periodic reports on Form 10-Q and Form 8-K. Unless
otherwise noted, Amgen is providing this information as of the date
of this news release and does not undertake any obligation to
update any forward-looking statements contained in this document as
a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
Discovery or identification of new product candidates or
development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product
candidate or development of a new indication for an existing
product will be successful and become a commercial product.
Further, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately
modeled by computer or cell culture systems or animal models. The
length of time that it takes for us to complete clinical trials and
obtain regulatory approval for product marketing has in the past
varied and we expect similar variability in the future. Even when
clinical trials are successful, regulatory authorities may question
the sufficiency for approval of the trial endpoints we have
selected. We develop product candidates internally and through
licensing collaborations, partnerships and joint ventures. Product
candidates that are derived from relationships may be subject to
disputes between the parties or may prove to be not as effective or
as safe as we may have believed at the time of entering into such
relationship. Also, we or others could identify safety, side
effects or manufacturing problems with our products after they are
on the market.
Our results may be affected by our ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are
affected by pricing pressure, political and public scrutiny and
reimbursement policies imposed by third-party payers, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment. Furthermore, our research, testing,
pricing, marketing and other operations are subject to extensive
regulation by domestic and foreign government regulatory
authorities. We or others could identify safety, side effects or
manufacturing problems with our products after they are on the
market. Our business may be impacted by government investigations,
litigation and product liability claims. In addition, our business
may be impacted by the adoption of new tax legislation or exposure
to additional tax liabilities. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the
U.S. government, we could become subject to significant sanctions.
Further, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent
applications may be challenged, invalidated or circumvented by our
competitors, or we may fail to prevail in present and future
intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities
and also depend on third parties for a portion of our manufacturing
activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. In
addition, we compete with other companies with respect to many of
our marketed products as well as for the discovery and development
of new products. Further, some raw materials, medical devices and
component parts for our products are supplied by sole third-party
suppliers. The discovery of significant problems with a product
similar to one of our products that implicate an entire class of
products could have a material adverse effect on sales of the
affected products and on our business and results of operations.
Our efforts to acquire other companies or products and to integrate
the operations of companies we have acquired may not be successful.
We may not be able to access the capital and credit markets on
terms that are favorable to us, or at all. We are increasingly
dependent on information technology systems, infrastructure and
data security. Our stock price is volatile and may be affected by a
number of events. Our business performance could affect or limit
the ability of our Board of Directors to declare a dividend or our
ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release
related to new indications for Amgen's products is preliminary and
investigative and is not part of the labeling approved by the U.S.
Food and Drug Administration for the products. The products are not
approved for the investigational use(s) discussed in this news
release and no conclusions can or should be drawn regarding the
safety or effectiveness of the products for these uses.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(Media)
Kristen Neese, 805-313-8267
(Media)
Arvind Sood, 805-447-1060
(Investors)
References
|
1.
|
Moreau P, Richardson
PG, Cavo M, et al. Proteasome Inhibitors in Multiple Myeloma: 10
Years Later. Blood. 2012; 120(5):947-959.
|
2.
|
Kyprolis®
[http://www.kyprolis-hcp.com/]. Thousand Oaks, CA: Amgen;
2016.
|
3.
|
Kortuem KM and
Stewart AK. Carfilzomib. Blood. 2012; 121(6):893-897.
|
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