FDA accepts BMS’s applications for Opdivo + Yervoy and Opdivo + chemotherapy for unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 28, 2022.

“Last year, over 19,000 people were diagnosed with esophageal cancer in the United States, and 15,000 people died as a result of this very aggressive disease,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “Additional treatment options are needed to improve upon outcomes achieved with the current standard of care. We are confident that our immunotherapy-based combinations can provide further clinical benefit and address this critical need.”

The filings were based on results from the pivotal Phase III CheckMate -648 trial, marking the fourth global trial in which Opdivo or Opdivo-based treatment combinations demonstrated a significant benefit for patients with upper gastrointestinal cancers. In CheckMate -648, both Opdivo-based treatment combinations — Opdivo plus Yervoy and Opdivo plus chemotherapy — demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy in patients with unresectable advanced or metastatic ESCC with tumor cell PD-L1 expression greater than 1%, as well as in the all-randomized population. Opdivo plus Yervoy is the first dual immunotherapy combination to demonstrate a superior survival benefit versus chemotherapy in this setting. The safety profiles of Opdivo plus Yervoy and Opdivo plus chemotherapy were consistent with the known safety profiles of the individual components.