Bristol Myers Gets CHMP Backing for Second-Line Breyanzi

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 [e-mail]

(END) Dow Jones Newswires

March 31, 2023 08:57 ET (12:57 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.