LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) 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.
“We are very pleased to announce this 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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