Bristol Myers Gets CHMP Backing for Expanded Breyanzi, Opdivo/Yervoy Uses

Dow Jones

Jan 31, 2025

By Colin Kellaher

Bristol Myers Squibb said a key European regulatory committee is backing expanded approvals for its CAR-T cell therapy Breyanzi and its Opdivo plus Yervoy cancer-drug combination.

Bristol Myers on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Breyanzi for the treatment of adults with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy.

Breyanzi is already approved in several lymphoma indications in Europe.

The Princeton, N.J., biopharmaceutical company said the CHMP also recommended approval of Opdivo plus Yervoy for the first-line treatment of adults with unresectable or advanced hepatocellular carcinoma, which accounts for up to 85% of all liver cancers.

The Opdivo/Yervoy combination is already approved in several cancer indications in Europe.

The European Commission, which generally follows CHMP's advice, will now review the recommendations, with its decisions expected within about two months.

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

(END) Dow Jones Newswires

January 31, 2025 07:52 ET (12:52 GMT)

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