Puma Biotechnology Receives FDA Advisory Committee Support for Neratinib
May 24 2017 - 1:29PM
Business Wire
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, today announced that the U.S. Food and Drug
Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC)
voted 12 - 4 to recommend approval of PB272 (neratinib) for the
extended adjuvant treatment of HER2-positive early stage breast
cancer based on finding that the risk-benefit profile of neratinib
is favorable.
The ODAC vote was based on a review of the clinical development
program that included 11 trials in breast cancer and represented
approximately 2,000 patient years’ experience. The focus of the
meeting was the Phase III ExteNET study, which provided one year of
continuous therapy with neratinib after patients completed one year
of therapy with a trastuzumab-based regimen. The study demonstrated
a statistically significant 33% relative reduction of risk of
invasive disease recurrence within two years after treatment.
“Despite advances in adjuvant therapy for HER2-positive breast
cancer, disease recurrence remains a risk. Since there are no
effective therapies for patients whose disease recurs, there is an
important need for additional options to further reduce the risk of
recurrence,” said Alan H. Auerbach, Chief Executive Officer and
President of Puma Biotechnology.
ODAC is an independent panel of experts that evaluates data
concerning the efficacy and safety of marketed and investigational
cancer treatments and makes appropriate recommendations to the FDA.
Its vote is not binding, but is considered by the FDA in its
decision making process.
“We appreciate the committee’s comments and the support of the
many clinicians, patients and advocates who participated in today’s
meeting,” Mr. Auerbach added. “We look forward to further
discussion with the FDA.”
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. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170524006021/en/
Puma Biotechnology, Inc.Alan H. Auerbach or Mariann Ohanesian,
+1 424 248
6500info@pumabiotechnology.comir@pumabiotechnology.comorRusso
PartnersDavid Schull or Amiad Finkelthal,
+1-212-845-4271david.schull@russopartnersllc.comamiad.finkelthal@russopartnersllc.com
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