FDA Grants Amgen’s Gastric Cancer Drug Breakthrough Designation

The FDA has granted a Breakthrough Therapy designation for Amgen’s investigational antibody bemarituzumab as a first-line treatment for gastric cancer.

The targeted therapy is for tumors that overexpress the fibroblast growth factor receptor 2b (FGFR2b) protein.

The breakthrough designation covers bemarituzumab combined with the chemotherapy FOLFOX6 (fluoropyrimidine, leucovorin and oxaliplatin) for overexpressing FGFR2b and human epidermal growth factor receptor 2 (HER2)-negative gastric and gastroesophageal cancer.

The FDA granted the breakthrough status based on results of a phase 2 study showing the drug plus chemotherapy significantly improved survival for patients with at least 10 percent tumor cell overexpression of FGFR2b.