Amgen Receives FDA Approval for Bemarituzumab in FGFR2b-Positive Gastric Cancer

Amgen today announced that the FDA has approved bemarituzumab plus modified FOLFOX6 for the first-line treatment of adults with FGFR2b-overexpressing locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. In the Phase 3 SPOTLIGHT trial, bemarituzumab plus mFOLFOX6 demonstrated a statistically significant improvement in progression-free survival compared to placebo plus mFOLFOX6. This approval provides patients with FGFR2b-positive gastric cancer a new targeted treatment option and represents the first FGFR2b-targeted therapy approved for gastric cancer.