Bristol Myers Gets Positive CHMP Opinion for Opdivo in Gastric, Esophageal Cancers

By Colin Kellaher

Bristol Myers Squibb Co. on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of its cancer drug Opdivo in certain cancers of the stomach and esophagus.

The New York biopharmaceutical company said the recommendation covers Opdivo in combination with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of adults with HER2-negative advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score of at least 5.

Bristol Myers said the recommendation is based on results from a Phase 3 study in which Opdivo plus chemotherapy showed superior overall survival versus chemotherapy alone.

The European Commission, which generally follows CHMP's advice, will now review the recommendation.

Opdivo, which harnesses the body's own immune system to fight cancer, is currently approved in more than 65 countries across multiple cancers.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

September 17, 2021 07:30 ET (11:30 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.