Tag: Puma Biotechnology

July 18, 2017 Off

FDA OK’s Puma Biotechnology’s cancer drug

The U.S. Food and Drug Administration has approved Puma Biotechnology’s neratinib for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

May 25, 2017 Off

FDA’s Advisory Committee recommends approval of Puma Biotechnology’s breast cancer drug

By Dino Mustafić

FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended approval of Puma Biotechnology’s PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer based on finding that the risk-benefit profile of neratinib is favorable.