By Colin Kellaher

 

Bristol-Myers Squibb Co. on Thursday said the U.S. Food and Drug Administration accepted for priority review its biologics license application for its lisocabtagene maraleucel immunotherapy in certain forms of large B-cell lymphoma.

The New York biopharmaceutical company said the application covers lisocabtagene maraleucel for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies.

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 to six months from the standard 10 months.

Bristol-Myers said the agency set a target action date of Aug. 17 for the application.

 

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

 

(END) Dow Jones Newswires

February 13, 2020 07:49 ET (12:49 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.
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