Bristol Myers: FDA Accepts SBLA For Opdivo Plus Yervoy, Opdivo Plus Chemotherapy In ESCC Patients

(RTTNews) - Bristol Myers Squibb (BMY) announced Monday that the U.S. Food and Drug Administration has accepted the supplemental Biologics License Applications or sBLA for both Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy for unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma or ESCC.

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

The applications for the dual-immunotherapy combination and immunotherapy plus chemotherapy combination as first-line treatments for adult patients are based on Phase 3 CheckMate -648 trial. In the trial, both Opdivo-based combinations demonstrated a significant overall survival benefit over chemotherapy alone.

The company noted that 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.

CheckMate -648 is one of four positive Phase 3 trials in which Opdivo or Opdivo-based treatment combinations demonstrated a significant benefit for patients with upper gastrointestinal cancers.

The company presented the results from CheckMate -648 during the 2021 American Society of Clinical Oncology Annual Meeting and were selected for the official ASCO press program.