- Neratinib becomes the first anti-HER2
treatment to be FDA-approved as extended adjuvant therapy for
early-stage HER2-positive breast cancer following adjuvant
trastuzumab-based therapy.
- Treatment with neratinib resulted in a
34% 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) today announced that the
U.S. Food and Drug Administration (FDA) has approved NERLYNX™
(neratinib), formerly known as PB272, a once-daily oral tyrosine
kinase inhibitor for the extended adjuvant treatment of adult
patients with early stage HER2-overexpressed/amplified breast
cancer, following adjuvant trastuzumab-based therapy. Puma expects
neratinib to become commercially available in September 2017 and to
be marketed as NERLYNX.
FDA approval was based on the Phase III ExteNET trial, a
multicenter, randomized, double-blind, placebo-controlled trial of
neratinib following adjuvant trastuzumab treatment. Women (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, invasive disease-free survival (iDFS) was 94.2%
in patients treated with neratinib compared with 91.9% in those
receiving placebo (HR 0.66; 95% CI: 0.49, 0.90, p=0.008).
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.
"The fear of recurrence is ever present in the minds of most
women with breast cancer, from the moment they are diagnosed to
long after they finish adjuvant treatment," said Marisa C. Weiss,
M.D., Chief Medical Officer and Founder of Breastcancer.org. “New
and effective innovative therapeutic options provide huge hope to
patients and their families, giving them a better chance of
overcoming breast cancer with a chance for a full life.”
“Despite advances in the treatment of early stage HER2-positive
breast cancer, there remains a need for further therapeutic
improvements in order to attempt to further reduce the risk of
disease recurrence,” said Puma Biotechnology CEO and President Alan
H. Auerbach. “We are pleased to be able to bring this new medicine
to patients with breast cancer. We 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.”
The full prescribing information for NERLYNX will be made
available at WWW.NERLYNX.COM. 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 NERLYNX dose and continued during the
first 2 cycles (56 days) of treatment and as needed thereafter. A
Marketing Authorisation Application for neratinib is under review
by the European Medicines Agency (EMA).
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.
Indication
NERLYNX™ is a tyrosine 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.
Patient Support
Puma has developed the Puma Patient Lynx support program to
provide patients and healthcare providers with assistance related
to questions on accessing neratinib and referrals to resources that
can help with reimbursement and financial assistance. More
information on the Puma Patient Lynx program can be found at
www.NERLYNX.com or (1-855-816-5421).
Important Safety Information
There are possible side effects of NERLYNX. Patients must
contact their doctor right away if they experience any of these
symptoms. NERLYNX treatment may be stopped or the dose may be
lowered if the patient experiences any of these side effects.
Diarrhea
Diarrhea is a common side effect of NERLYNX. The diarrhea may be
severe, and you may get dehydrated. Your healthcare provider should
prescribe the medicine loperamide for you during your first 2
cycles (56 days) of NERLYNX and then as needed. To help prevent or
reduce diarrhea:
- You should start taking loperamide with
your first dose of NERLYNX.
- Keep taking loperamide during the first
2 cycles (56 days) of NERLYNX treatment and then as needed. Your
healthcare provider will tell you exactly how much and how often to
take loperamide.
- While taking loperamide, you and your
healthcare provider should try to keep the number of bowel
movements that you have at 1 or 2 bowel movements each day.
- Tell your healthcare provider if you
have more than 2 bowel movements in 1 day, or you have diarrhea
that does not go away.
Contact your healthcare provider right away if you have
severe diarrhea or if you have diarrhea along with weakness,
dizziness, or fever.
Liver Problems
Changes in liver function tests are common with NERLYNX. The
patient’s doctor will do tests before starting treatment, monthly
during the first 3 months, and then every 3 months as needed during
treatment with NERLYNX. NERLYNX treatment may be stopped or the
dose may be lowered if your liver tests show severe problems.
Symptoms of liver problems may include tiredness, nausea, vomiting,
pain in the right upper stomach-area (abdomen), fever, rash,
itching, yellowing of your skin or whites of your eyes.
Pregnancy
Patients should tell their doctor if they are planning to become
pregnant, are pregnant, plan to breastfeed, or are breastfeeding.
NERLYNX can harm your unborn baby. Birth control should be used
while a patient is receiving NERLYNX and for at least 1 month after
the last dose. If patients are exposed to NERLYNX during pregnancy,
they must contact their healthcare provider right away.
Common side effects in patients treated with NERLYNX
In clinical studies, the most common side effects seen in
patients taking NERLYNX were diarrhea, nausea, abdominal pain,
fatigue, vomiting, rash, stomatitis (dry or inflamed mouth, or
mouth sores), decreased appetite, muscle spasms, dyspepsia, changes
in liver blood tests results, nail problems, dry skin, abdominal
distention, weight loss, and urinary tract infection.
Patients should tell their doctor right away if they are
experiencing any side effects. Report side effects to the FDA at
1-800-FDA-1088 or http://www.FDA.gov/medwatch.
Patients and caregivers may also report side effects to Puma
Biotechnology at 1-844-NERLYNX (1-844-637-5969).
Please see Full Prescribing Information, available at
www.NERLYNX.com.
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. 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 development of
the oral version of neratinib, and its most advanced drug
candidates are directed at the treatment of HER2-positive breast
cancer. The Company believes that neratinib has clinical
application in the treatment of several other cancers as well,
including non-small cell lung cancer and other tumor types that
over-express or have a mutation in HER2. 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 Company’s expectation that
neratinib will become commercially available in September 2017. All
forward-looking statements included in this press release 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 fact that the Company has no
product revenue and no products approved for marketing, the
Company's dependence on PB272, which is still under development and
may never receive regulatory approval, the challenges associated
with conducting and enrolling clinical trials, the risk that the
results of clinical trials may not support the Company's drug
candidate claims, even if approved, the risk that physicians and
patients may not accept or use the Company's products, the
Company's reliance on third parties to conduct its clinical trials
and to formulate and manufacture its drug candidates, risks
pertaining to securities class action, derivative and defamation
lawsuits, the Company's dependence on licensed intellectual
property, and the other 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, 2016.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170717006247/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
Puma Biotechnology (NASDAQ:PBYI)
Historical Stock Chart
From Aug 2024 to Sep 2024
Puma Biotechnology (NASDAQ:PBYI)
Historical Stock Chart
From Sep 2023 to Sep 2024