On March 18, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI) reported that its licensing partner Specialised Therapeutics Asia (STA) has received marketing authorization from Australia’s Therapeutic Goods Administration (TGA) to commercialize NERLYNX (neratinib) in Australia for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab based therapy (Press release, Puma Biotechnology, MAR 18, 2019, View Source [SID1234534408]). STA has submitted regulatory applications to gain approval to introduce NERLYNX in Singapore. Further applications are planned by STA in other countries in South East Asia, including Malaysia, Brunei, Vietnam and Thailand.
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TGA approval was based on the Phase III ExteNET trial, a multicenter, randomized, double-blind, placebo-controlled trial of neratinib 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 neratinib (n=1420) or placebo (n=1420) 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 neratinib 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, weight loss, and urinary tract infection. The most common adverse reaction leading to discontinuation was diarrhea, which was observed in 16.8% of neratinib-treated patients. Hepatotoxicity or increases in liver transaminases led to drug discontinuation in 1.7% of neratinib-treated patients.
"TGA approval marks the first time Australian women are being presented with an opportunity for extended-adjuvant therapy that will reduce the risk of disease recurrence in patients who would otherwise have had a relapse," said Carlo Montagner, Chief Executive Officer of Specialised Therapeutics. "We are pleased to be at the forefront of this new treatment paradigm and look forward to changing outcomes for these women and their families."
Puma Biotechnology’s CEO and President, Alan H. Auerbach, added, "Reducing the risk of disease recurrence remains a need for patients, despite advances in the treatment of early stage HER2-positive breast cancer. We are pleased that our partner STA will be bringing this new medicine to patients throughout Australia and 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. We are committed to continuing to expand NERLYNX accessibility to patients around the world."
About HER2-Positive Breast Cancer
Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.