Bristol Myers Gets FDA OK of Breyanzi in Follicular Lymphoma
By Colin Kellaher
Bristol Myers Squibb has won U.S. Food and Drug Administration expanded approval of its CAR-T cell therapy Breyanzi for adults with relapsed or refractory follicular lymphoma who have had two or more prior lines of systemic therapy.
The Princeton, N.J., biopharmaceutical company late Wednesday said the FDA granted accelerated approval for the new indication, adding that continued approval may be contingent upon verification and description of clinical benefit in confirmatory studies.
Breyanzi, which was already approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma after at least one line of therapy and for relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy, generated sales of $364 million last year, double 2022 levels.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 16, 2024 06:48 ET (10:48 GMT)
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