Bristol Myers: EU recommends treatment

(CercleFinance.com) - Bristol Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi (lisocabtagene maraleucel; liso-cel), for Breyanzi CAR-T cell therapy in relapsed or refractory follicular lymphoma.


The European Commission (EC), which has the power to approve medicines for the European Union (EU), will now examine the CHMP's recommendation.

As a company at the forefront of advancing therapies that transform outcomes for some of the most difficult-to-treat cancers, CAR-T cell therapies are an important focus of our research, and Breyanzi remains the cornerstone of our cell therapy portfolio and pipeline, Bristol Myers Squibb said.

The CHMP adopted a positive opinion based on data from the global Phase 2 TRANSCEND FL study, the largest clinical trial to date evaluating CAR-T cell therapy in patients with relapsed or refractory indolent non-Hodgkin's lymphoma (NHL).


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