LOS ANGELES--(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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