Bristol-Myers Squibb (BMY) Announces FDA Accepts Applications for Opdivo + Yervoy and Opdivo + Chemotherapy for Unresectable Advanced, Recurrent or Metastatic ESCC

Go back to Bristol-Myers Squibb (BMY) Announces FDA Accepts Applications for Opdivo + Yervoy and Opdivo + Chemotherapy for Unresectable Advanced, Recurrent or Metastatic ESCC

U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy for Unresectable Advanced, Recurrent or Metastati

September 27, 2021 7:06 AM EDT

Applications based on Phase 3 CheckMate -648 trial, in which both Opdivo-based combinations demonstrated a significant overall survival benefit over chemotherapy alone

The U.S. Food and Drug Administration assigned a target action date of May 28, 2022

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

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