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Puma Announces Availability of NERLYNX™ (neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer in the United States

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that NERLYNX™ (neratinib) tablets, formerly known as PB272, is now commercially available by prescription in the United States. The U.S. Food and Drug Administration (FDA) approved NERLYNX on July 17, 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy.

“Like many women with breast cancer, those with HER2-positive disease often struggle with anxiety and fear of recurrence”

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FDA approval was based on the Phase III ExteNET trial, a multicenter, randomized, double-blind, placebo-controlled trial of NERLYNX following adjuvant trastuzumab treatment. Women (n=2,840) with early stage HER2-positive breast cancer and within two years of completing adjuvant trastuzumab were randomized to receive either NERLYNX (n=1,420) or placebo (n=1,420) for one year.

The results of the ExteNET trial demonstrated that after two years of follow-up, invasive disease-free survival (iDFS) was 94.2% in patients treated with NERLYNX compared with 91.9% in those receiving placebo (HR 0.66; 95% CI: 0.49, 0.90, p=0.008).

The most common adverse reactions (≥5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight loss, and urinary tract infection. The most common adverse reaction leading to discontinuation was diarrhea, which was observed in 16.8% of NERLYNX-treated patients. Increases in liver transaminases led to drug discontinuation in 1.7% of NERLYNX-treated patients.

“Like many women with breast cancer, those with HER2-positive disease often struggle with anxiety and fear of recurrence,” said Jennifer Merschdorf, Chief Executive Officer of Young Survival Coalition. "We are always eager for treatment advances that may provide an opportunity to further reduce the risk of recurrence.”

“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 NERLYNX clinical development program and, more specifically, the ExteNET trial.”

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

The full prescribing information for NERLYNX is available at www.NERLYNX.com. The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the...


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