By Colin Kellaher

 

Bristol Myers Squibb Co. on Monday said the U.S. Food and Drug Administration granted priority review to its application for a fixed-dose combination of the immune checkpoint inhibitor relatlimab and its cancer drug Opdivo in patients with unresectable or metastatic melanoma.

The New York biopharmaceutical company said the application, which covers adults and children ages 12 and up with the skin cancer, is based on a Phase 2/3 study in which the combination showed a statistically significant and clinically meaningful progression-free survival benefit over Opdivo alone.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. Bristol Myers said the agency set a target action date of March 19, 2022, for the new application.

Bristol Myers said approval would mark the introduction of relatlimab, its first lymphocyte-activation gene 3, or LAG-3, blocking antibody and its third distinct checkpoint inhibitor. The company is studying relatlimab in combination with other agents in a variety of tumor types.

 

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

 

(END) Dow Jones Newswires

September 20, 2021 07:52 ET (11:52 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Sep 2021 to Oct 2021 Click Here for more Bristol Myers Squibb Charts.
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Oct 2020 to Oct 2021 Click Here for more Bristol Myers Squibb Charts.