Bristol Myers Gets CHMP Backing for Second-Line Breyanzi
March 31 2023 - 9:12AM
Dow Jones News
By Colin Kellaher
Bristol Myers Squibb Co. on Friday said the European Medicines
Agency's Committee for Medicinal Products for Human Use has
recommended approval of its CAR-T cell therapy Breyanzi for use in
adults with relapsed or refractory large B-cell lymphoma after one
prior therapy.
The New York biopharmaceutical company said the recommendation
covers adults with diffuse large B-cell lymphoma, high grade B-cell
lymphoma, primary mediastinal large B-cell lymphoma and follicular
lymphoma grade 3B who relapsed within 12 months from completion of,
or are refractory to, first-line chemoimmunotherapy.
Bristol Myers said it expects a decision from the European
Commission, which generally follows the CHMP's advice, within about
two months.
Breyanzi is already approved in Europe after two or more lines
of systemic therapy and last year won U.S. Food and Drug
Administration approval as a second-line treatment.
Bristol Myers reported 2022 Breyanzi revenue of $182 million,
more than double its 2021 levels.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 31, 2023 08:57 ET (12:57 GMT)
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