FDA Grants Priority Review for Opdivo for Several Gastrointestinal Cancers

January 20, 2021
Darlene Dobkowski, MA

The priority review will focus on Opdivo with chemotherapy for the treatment several gastrointestinal cancers, which has recently become a rising area in novel treatment development.

The Food and Drug Administration (FDA) approved an application from Bristol Myers Squibb for the priority review of Opdivo (nivolumab) for the treatment of patients with metastatic or advanced gastric cancer, esophageal adenocarcinoma or gastrointestinal junction cancer.

Opdivo, a PD-1 immune checkpoint inhibitor that utilizes a patient’s immune system to reestablish its anti-tumor response, would be given in combination with platinum- and fluoropyrimidine-based chemotherapy to treat these gastrointestinal cancers.

“Today’s filing acceptance by the FDA marks important progress for the gastrointestinal cancer community and builds on our momentum of advancing immunotherapies to help improve the lives of those with advanced gastric and esophageal tumors,” said Dr. Ian M. Waxman, development lead of gastrointestinal cancers for Bristol Myers Squibb, in a press release from the company.

Approval of this priority review application was based on findings from the phase 3 CheckMate-649 trial, which determined that Opdivo improves progression-free survival and overall survival in patients with unresectable advanced or metastatic gastric cancer, esophageal adenocarcinoma or gastrointestinal junction cancer.

“The positive results of the CheckMate-649 trial are potentially practice-changing, and we look forward to working with the FDA to possibly bring the first immunotherapy-based treatment option to frontline patients, for whom no novel therapies have been made available in the last decade,” said Waxman.

The FDA assigned a Prescription Drug User Fee Act date, or a deadline by which action must be taken by the Agency, for Opdivo of May 25, 2021.

Last month, the FDA also accepted a priority review for Keytruda (pembrolizumab) in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic esophagus cancer and gastroesophageal junction cancer.

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