- Neratinib becomes the first anti-HER2
treatment to be EC-approved as extended adjuvant therapy for early
stage hormone receptor positive HER2-positive breast cancer
following adjuvant trastuzumab-based therapy
- Treatment with neratinib in the
approved European indication resulted in a 51% reduction in the
risk of invasive disease recurrence or death versus placebo after
patients completed one year of therapy following a
trastuzumab-based regimen
- Neratinib addresses an unmet medical
need, as up to 25% of HER2-positive early stage breast cancer
patients treated with trastuzumab-based adjuvant treatment
experience a recurrence
Puma Biotechnology, Inc. (Nasdaq:PBYI) announced that the
European Commission (EC), has granted marketing authorisation for
NERLYNX® (neratinib) for the extended adjuvant treatment of adult
patients with early stage hormone receptor positive
HER2-overexpressed/amplified breast cancer and who are less than
one year from the completion of prior adjuvant trastuzumab based
therapy.
EC approval was based on the Phase III ExteNET trial, a
multicenter, randomized, double-blind, placebo-controlled trial of
neratinib following adjuvant trastuzumab treatment. Patients
(n=2,840) with early stage HER2-positive breast cancer and within
two years of completing adjuvant trastuzumab were randomized to
receive either neratinib (n=1420) or placebo (n=1420) for one
year.
The results of the ExteNET trial demonstrated that after two
years of follow-up, for patients with hormone receptor positive,
HER2-positive early stage breast cancer patients who were treated
within one year after the completion of trastuzumab based adjuvant
therapy, invasive disease-free survival (iDFS) was 95.3% in the
patients treated with neratinib compared with 90.8% in those
receiving placebo (hazard ratio = 0.49; 95% CI: (0.30, 0.78);
p=0.002)
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, weight loss, and
urinary tract infection. The most common adverse reaction leading
to discontinuation was diarrhea, which was observed in 16.8% of
neratinib-treated patients. Hepatotoxicity or increases in liver
transaminases led to drug discontinuation in 1.7% of
neratinib-treated patients.
“Reducing the risk of disease recurrence remains a need for
patients, despite advances in the treatment of early stage
HER2-positive breast cancer,” said Puma Biotechnology CEO and
President Alan H. Auerbach. “We are pleased to bring this new
medicine to patients in Europe and would like to express our
appreciation to the patients, caregivers and physicians who
contributed to the neratinib clinical development program and, more
specifically, the ExteNET trial. We are committed to continuing to
expand NERLYNX accessibility to patients worldwide. We expect
NERLYNX to be commercially available in Europe in 2019, beginning
with our launch in Germany during the first half of 2019 and
followed by additional countries throughout Europe in the second
half of 2019.”
The approval of NERLYNX by the European Commission follows the
positive opinion issued by the Committee for Medicinal Products for
Human Use of the European Medicines Agency in June 2018.
Neratinib was approved by the U.S. Food and Drug Administration
(FDA) in July 2017 for the extended adjuvant treatment of adult
patients with early stage HER2-positive breast cancer following
adjuvant trastuzumab-based therapy, and is marketed in the United
States as NERLYNX® (neratinib) tablets.
About HER2-Positive Breast Cancer
Approximately 20 to 25 percent 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 trastuzumab experience recurrence.
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. Puma in-licenses the global
development and commercialization rights to three drug candidates —
PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357.
Neratinib, oral was approved by the U.S. Food and Drug
Administration in July 2017 for the extended adjuvant treatment of
adult patients with early stage HER2-overexpressed/amplified breast
cancer, following adjuvant trastuzumab-based therapy, and is
marketed in the United States as NERLYNX® (neratinib) tablets.
NERLYNX is a registered trademark of Puma Biotechnology, Inc.
Important EU NERLYNX® (neratinib) Safety
Information
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 randomized Phase 3 clinical trial (n=2840). The most common
adverse reactions of any grade were diarrhoea (93.6%), nausea
(42.5%), fatigue (27.3%), vomiting (26.8%), abdominal pain (22.7%),
rash (15.4%), decreased appetite (13.7%), abdominal pain upper
(13.2%), stomatitis (11.2%), and muscle spasms (10.0%).
The most common Grade 3-4 adverse reactions were diarrhoea
(Grade 3, 36.9% and Grade 4, 0.2%) and vomiting (Grade 3, 3.4% and
Grade 4, 0.1%).
Adverse reactions reported as serious included diarrhoea (1.9%),
vomiting (1.3%), dehydration (1.1%), nausea (0.5%), alanine
aminotransferase increased (0.4%), aspartate aminotransferase
increased (0.4%), abdominal pain (0.3%), fatigue (0.3%) and
decreased appetite (0.2%).
For full European prescribing information, please refer to
the NERLYNX (neratinib) Summary of Product Characteristics on the
European Medicines Agency website
(http://www.ema.europa.eu/ema/).
Important Safety Information Regarding
NERLYNX® (neratinib) U.S. Indication
NERLYNX® (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor
indicated for the extended adjuvant treatment of adult patients
with 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 inpatients 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.
To help ensure patients have access to NERLYNX, Puma has
implemented the Puma Patient Lynx support program to assist
patients and health care 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.
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.
Further information about Puma Biotechnology can be found at
www.pumabiotechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the worldwide expansion of NERLYNX.
All forward-looking statements involve risks and uncertainties that
could cause the Company’s actual results to differ materially from
the anticipated results and expectations expressed in these
forward-looking statements. These statements are based on current
expectations, forecasts and assumptions, and actual outcomes and
results could differ materially from these statements due to a
number of factors, which include, but are not limited to, the risk
factors disclosed in the periodic and current reports filed by the
Company with the Securities and Exchange Commission from time to
time, including the Company’s Annual Report on Form 10-K for the
year ended December 31, 2017 and its Quarterly Report on Form 10-Q
for the quarter ended June 30, 2018. Readers are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. The Company assumes no obligation
to update these forward-looking statements, except as required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20180904005210/en/
Puma Biotechnology, Inc.Alan H. Auerbach / Mariann Ohanesian,
+1-424-248-6500info@pumabiotechnology.comir@pumabiotechnology.comorRusso
PartnersDavid Schull / Amiad Finkelthal,
+1-212-845-4200david.schull@russopartnersllc.comamiad.finkelthal@russopartnersllc.com
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