Puma Biotechnology Announces FDA Advisory Committee to Review Neratinib for the Extended Adjuvant Treatment of HER2-Positive ...
April 17 2017 - 8:03AM
Business Wire
Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical
company, today announced that the U.S. Food and Drug Administration
(FDA) has scheduled the New Drug Application (NDA) for neratinib
for discussion by the Oncologic Drugs Advisory Committee (ODAC) on
May 24, 2017. Neratinib is an investigational therapy for the
extended adjuvant treatment of early stage HER2-positive breast
cancer that has previously been treated with a trastuzumab
containing regimen.
ODAC is an independent panel of experts that evaluates data
concerning the efficacy and safety of marketed and investigational
products for use in the treatment of cancer and makes appropriate
recommendations to the FDA. Although the FDA will consider the
recommendation of the panel, the final decision regarding the
approval of the product is made by the FDA solely, and the
recommendations by the panel are non-binding.
Puma Biotechnology announced on September 20, 2016 that the FDA
had accepted for filing the NDA for neratinib. The NDA for
neratinib is based on results from both the Phase III ExteNET trial
in extended adjuvant early stage HER2-positive breast cancer and
the Phase II CONTROL trial in extended adjuvant early stage
HER2-positive breast cancer.
About Puma BiotechnologyPuma 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
ODAC’s scheduled review of the NDA for neratinib. 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, 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/20170417005369/en/
Puma Biotechnology, Inc.Alan H. Auerbach or Mariann Ohanesian,
+1 424 248
6500info@pumabiotechnology.comir@pumabiotechnology.comorRusso
PartnersDavid Schull,
+1-212-845-4271david.schull@russopartnersllc.com
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