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The U.S. Food and Drug Administration on Monday approved Puma Biotechnology Inc (NASDAQ:PBYI)'s NERLYNX (neratinib), formerly known as PB272, for the treatment of breast cancer.
Neratinib is the first anti-HER2 treatment to gain the FDA's approval for extended adjuvant therapy for early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, Puma Biotechnology stated in a press release. The company now expects to make neratinib commercially available in September 2017 and will be marketed as NERLYNX.
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Neratinib is intended to address an unmet need, as up to 25 percent of HER2-positive early-stage breast cancer patients treated with trastuzumab-based adjuvant treatment experience a recurrence.
Patients treated with neratinib resulted in a 34 percent reduction in the risk of invasive disease recurrence or death versus placebo after patients completed one year of therapy following a trastuzumab-based regimen.
Rough Year For PBYI
The FDA's announcement follows a rough year for Puma Biotechnology. Last November, the stock plunged more than 20 percent in one day after an interim analysis called into question the safety profile of neratinib as 90 percent of patients experienced diarrhea, and 19 percent suffered serious cases.
But in Puma Biotechnology's latest release, the company noted that diarrhea was observed in 16.8 percent of neratinib-treated patients.
"Despite advances in the treatment of early stage HER2-positive breast cancer, there remains a need for further therapeutic improvements in order to attempt to further reduce the risk of disease recurrence," said Puma Biotechnology CEO and President Alan H. Auerbach. "We are pleased to be able to bring this new medicine to patients with breast cancer. We would like to express our appreciation to the patients, caregivers and physicians who contributed to the neratinib clinical development program and, more specifically, the ExteNET trial."
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Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.