Puma Biotechnology Announces U.S. FDA Acceptance of New Drug Application for PB272 (Neratinib) for Extended Adjuvant Treatmen...
September 20 2016 - 08:01AM
Business Wire
Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical
company, announced that the U.S. Food and Drug Administration (FDA)
has accepted for review the New Drug Application (NDA) for its lead
product candidate PB272 (neratinib) for the extended adjuvant
treatment of patients with early stage HER2-overexpressed/amplified
breast cancer who have received prior adjuvant trastuzumab
(Herceptin®)-based therapy.
“The FDA acceptance of our NDA is an important regulatory
milestone,” said Alan H. Auerbach, Chief Executive Officer and
President of Puma. “Although the use of trastuzumab in the adjuvant
setting has led to a reduction in disease recurrence in patients
with early stage HER2-positive breast cancer, there remains an
unmet clinical need to further reduce the risk of recurrence and
improve outcome following trastuzumab therapy. We believe that
neratinib may be able to provide this type of improvement to
further help patients with this disease. We look forward to working
with the FDA during their review of this submission.”
The submission is supported by the results of the ExteNET Phase
III study, in which treatment with neratinib resulted in a 33%
reduction of risk of invasive disease recurrence or death versus
placebo (hazard ratio = 0.67, p = 0.009). The 2-year invasive
disease free survival (DFS) rate for the neratinib arm was 93.9%
and the 2-year invasive DFS rate for the placebo arm was 91.6%. For
the pre-defined subgroup of patients with hormone receptor positive
disease, the results of the trial demonstrated that treatment with
neratinib resulted in a 49% reduction of risk of invasive disease
recurrence or death versus placebo (hazard ratio = 0.51, p =
0.001). For the patients with hormone receptor positive disease,
the 2-year invasive DFS rate for the neratinib arm was 95.4% and
the 2-year invasive DFS rate for the placebo arm was 91.2%.
Results of the study were published online in The Lancet
Oncology on February 10, 2016.
The most frequently observed adverse event for the
neratinib-treated patients was diarrhea, with approximately 39.9%
of the neratinib-treated patients experiencing grade 3 or higher
diarrhea (1 patient (0.1%) had grade 4 diarrhea). Patients who
received neratinib in the ExteNET trial did not receive any
prophylaxis with antidiarrheal agents to prevent the
neratinib-related diarrhea. In patients with HER2-positive early
stage breast cancer who have previously been treated with adjuvant
trastuzumab and received anti-diarrheal prophylaxis with
loperamide, interim results of a Phase II study of neratinib
monotherapy demonstrated that treatment with prophylactic
loperamide reduced the rate of grade 3 or higher diarrhea to
between 13.0% and 18.5%.
About ExteNET
The ExteNET trial is a double-blind, placebo-controlled, Phase
III trial of neratinib versus placebo after adjuvant treatment with
trastuzumab (Herceptin) in women with early stage HER2-positive
breast cancer. The trial randomized 2,840 patients in 41 countries
with early-stage HER2-positive breast cancer who had undergone
surgery and adjuvant treatment with trastuzumab. After completion
of adjuvant treatment with trastuzumab, patients were randomized to
receive extended adjuvant treatment with either neratinib or
placebo for a period of one year. Patients were then followed for
recurrent disease, ductal carcinoma in situ (DCIS), or death for a
period of two years after randomization in the trial. The primary
endpoint of the trial was invasive DFS.
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160920005516/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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