LOS ANGELES--(BUSINESS WIRE)--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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