By Colin Kellaher

 

Bristol Myers Squibb Co. on Monday said the U.S. Food and Drug Administration will review its applications seeking approval of its blockbuster cancer drug Opdivo in combination with Yervoy or with chemotherapy as first-line treatments for adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.

The New York biopharmaceutical company said the FDA set a target action date of May 28, 2022, for the applications.

Bristol Myers said the applications are based on a Phase 3 study in which both Opdivo-based combinations showed a statistically significant and clinically meaningful overall survival benefit compared to chemotherapy alone.

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

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

September 27, 2021 07:59 ET (11:59 GMT)

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