Bristol Myers Squibb: FDA to Review Opdivo Combos in Esophageal Squamous Cell Carcinoma
September 27 2021 - 8:14AM
Dow Jones News
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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