The U.S. FDA has approved Puma Biotechnology’s drug for HER2 positive breast cancer

Puma Biotechnology Inc’s NERLYNX (neratinib), formerly known as PB272, has been approved by the U.S. Food and Drug Administration for the treatment of breast cancer. As indicated by Puma Biotechnology, 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. The company now expects to make neratinib commercially available in September 2017 and will be marketed as NERLYNX.

Up to 25 percent of HER2-positive early-stage breast cancer patients treated with trastuzumab-based adjuvant treatment experience a recurrence. Neratinib is intended to address this need. Patients treated with neratinib brought about a 34 percent reduction in the risk of invasive disease recurrence after patients completed one year of therapy following a trastuzumab-based regimen.

"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”, he added. Puma Biotechnology launched the drug in the US in July as a maintenance therapy and is now looking for EU approval as well.