Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical
company, announced today that NERLYNX® (neratinib) has been
included as a recommended treatment option in the latest National
Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in
Oncology Central Nervous System Cancers for Breast Cancer patients
with brain metastases. The NCCN designated NERLYNX in combination
with capecitabine as a category 2A treatment option and NERLYNX in
combination with paclitaxel as a category 2B treatment option. Use,
as designated for breast cancer patients with brain metastases, is
outside the FDA approved indication for NERLYNX and considered
investigational.
“Physicians use the NCCN Guidelines as the standard resource for
determining the best course of treatment for patients,” said Alan
H. Auerbach, Chairman, Chief Executive Officer and President of
Puma. “We believe the updated NCCN guidelines will increase
awareness, which will help assist patients, their caregivers and
their healthcare providers in making informed decisions while
treating this significant unmet need in advanced breast
cancer.”
About Brain Metastases in Breast Cancer
Breast cancer is one of three types of cancers that are most
likely to metastasize to the brain. Across all sub-types,
approximately 10-15% of women with metastatic breast cancer develop
brain metastases. This rate is as high as 30% for women with
advanced HER2+ disease.
About National Comprehensive Cancer Network
The National Comprehensive Cancer Network® (NCCN®), a
not-for-profit alliance of 27 of the world’s leading cancer centers
devoted to patient care, research, and education, is dedicated to
improving the quality, effectiveness, and efficiency of cancer care
so that patients can live better lives. Through the leadership and
expertise of clinical professionals at NCCN Member Institutions,
NCCN develops resources that present valuable information to the
numerous stakeholders in the health care delivery system. As the
arbiter of high-quality cancer care, NCCN promotes the importance
of continuous quality improvement and recognizes the significance
of creating clinical practice guidelines appropriate for use by
patients, clinicians, and other health care decision-makers.
Category 2A: Based upon lower-level evidence, there is uniform
NCCN consensus that the intervention is appropriate.
Category 2B: Based upon lower-level evidence, there is NCCN
consensus that the intervention is appropriate.
About HER2-Positive Breast Cancer
Approximately 20% to 25% of breast cancer tumors over-express
the HER2 protein. HER2-positive breast cancer is often more
aggressive than other types of breast cancer, increasing the risk
of disease progression and death. Although research has shown that
trastuzumab can reduce the risk of early stage HER2-positive breast
cancer returning after surgery, up to 25% of patients treated with
a trastuzumab-based regimen experience recurrence.
IMPORTANT SAFETY INFORMATION
NERLYNX ® (neratinib) tablets, for oral
use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor
indicated for the extended adjuvant treatment of adult patients
with early-stage HER2 overexpressed/amplified breast cancer, to
follow adjuvant trastuzumab-based therapy.
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
- Diarrhea: Aggressively manage
diarrhea occurring despite recommended prophylaxis with additional
antidiarrheals, fluids, and electrolytes as clinically indicated.
Withhold NERLYNX in patients experiencing severe and/or persistent
diarrhea. Permanently discontinue NERLYNX in patients experiencing
Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal
dose reduction.
- Hepatotoxicity: Monitor liver
function tests monthly for the first 3 months of treatment, then
every 3 months while on treatment and as clinically indicated.
Withhold NERLYNX in patients experiencing Grade 3 liver
abnormalities and permanently discontinue NERLYNX in patients
experiencing Grade 4 liver abnormalities.
- Embryo-Fetal Toxicity: NERLYNX
can cause fetal harm. Advise patients of potential risk to a fetus
and to use effective contraception.
ADVERSE REACTIONS: The most common adverse reactions (≥
5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash,
stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or
ALT increase, nail disorder, dry skin, abdominal distention,
epistaxis, weight decreased and urinary tract infection.
To report SUSPECTED ADVERSE REACTIONS, contact Puma
Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and
www.NERLYNX.com or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
DRUG INTERACTIONS:
- Gastric acid reducing agents: Avoid
concomitant use with proton pump inhibitors (PPI) and H2-receptor
antagonists. Separate NERLYNX by 3 hours after antacid dosing.
- Strong or moderate CYP3A4 inhibitors:
Avoid concomitant use.
- Strong or moderate CYP3A4 inducers:
Avoid concomitant use.
- P-glycoprotein (P-gp) substrates:
Monitor for adverse reactions of narrow therapeutic agents that are
P-gp substrates when used concomitantly with NERLYNX.
USE IN SPECIFIC POPULATIONS:
- Lactation: Advise women not to
breastfeed.
Please see Full Prescribing Information for
additional safety information.
The recommended dose of NERLYNX is 240 mg (six 40 mg tablets)
given orally once daily with food, continuously for one year.
Antidiarrheal prophylaxis should be initiated with the first dose
of NERLYNX and continued during the first 2 months (56 days) of
treatment and as needed thereafter.
To help ensure patients have access to NERLYNX, Puma has
implemented the Puma Patient Lynx support program to assist
patients and healthcare providers with reimbursement support and
referrals to resources that can help with financial assistance.
More information on the Puma Patient Lynx program can be found at
www.NERLYNX.com or 1-855-816-5421.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a
focus on the development and commercialization of innovative
products to enhance cancer care. The Company in-licenses the global
development and commercialization rights to three drug candidates —
PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357.
NERLYNX® (neratinib) is approved for commercial use by prescription
in the United States as extended adjuvant therapy for early stage
HER2-positive breast cancer following adjuvant trastuzumab-based
therapy and is marketed as NERLYNX. Neratinib is a potent
irreversible tyrosine kinase inhibitor that blocks signal
transduction through the epidermal growth factor receptors, HER1,
HER2 and HER4. Currently, the Company is primarily focused on the
commercialization of NERLYNX and the continued development of its
other advanced drug candidates directed at the treatment of
HER2-positive breast cancer. The Company believes that NERLYNX has
clinical application in the potential treatment of several other
cancers that over-express or have a mutation in HER2.
Further information about Puma Biotechnology can be found at
www.pumabiotechnology.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20180402005256/en/
Puma Biotechnology, Inc.Alan H. Auerbach or Mariann Ohanesian,
+1
424-248-6500info@pumabiotechnology.comir@pumabiotechnology.comorRusso
PartnersDavid Schull or Amiad Finkelthal,
+1-212-845-4200david.schull@russopartnersllc.comamiad.finkelthal@russopartnersllc.com
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