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.

FDA said that approval was based on the 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.

As the FDA reported, the major efficacy outcome measure was invasive disease-free survival (iDFS) defined as the time between the randomization date to the first occurrence of invasive recurrence (local/regional, ipsilateral or contralateral breast cancer), distant recurrence, or death from any cause, within two years and 28 days of follow-up. After two years, iDFS was 94.2% in patients treated with neratinib compared with 91.9% in those receiving placebo.