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.
