Puma’s controversial cancer drug secures FDA approval
The U.S. Food and Drug Administration was forced to draw a line in the sand on Monday, with its approval of neratinib (Nerlynx), an adjuvant treatment for patients with early stage HER2-positive breast cancer. Manufactured by Los Angeles, California-based Puma Biotechnology, neratinib polarized experts with its Phase 3 data showing marginal efficacy and high rates of side effects. Many have questioned whether the benefits really outweigh the risks. On Monday, FDA settled that debate by granting it marketing approval.