Bristol Myers Squibb Receives FDA Approval for Opdivo in Gastric and Gastroesophageal Junction Cancer

Bristol Myers Squibb today announced that the FDA has approved Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for adults with unresectable advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. The approval was based on results from the Phase 3 CheckMate-649 trial, which demonstrated a statistically significant improvement in overall survival. Patients receiving Opdivo plus chemotherapy had a median OS of 13.8 months compared to 11.6 months for chemotherapy alone. This approval provides a new treatment option for patients with this aggressive cancer type.