FDA Approves Puma’s Nerlynx for Breast Cancer

FDA has approved a Puma Biotechnology NDA for Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. FDA says Nerlynx is the first therapy approved to be taken after an initial treatment to further lower the risk of the cancer coming back. It is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.

Nerlynx is a kinase inhibitor that works by blocking several enzymes that promote cell growth. Approval is based on data from a 2,800-patient trial that measured the amount of time after the start of the trial that it took for the cancer to come back or for death to occur from any cause (invasive, disease-free survival). “After two years, 94.2% of patients treated with Nerlynx had not experienced cancer recurrence or death compared with 91.9% of patients receiving placebo,” FDA says.