Bristol Myers: receives EU approval

(CercleFinance.com) - Bristol Myers Squibb has announced that the European Commission (EC) has granted approval to Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.


The decision is based on the results of the global Phase 2 TRANSCEND FL trial, the largest clinical trial to date to evaluate a CAR-T cell therapy in patients with relapsed or refractory indolent non-Hodgkin's lymphoma (NHL).

Breyanzi demonstrated durable clinical benefit, with 75.7% of patients still responding at 18 months, and a consistent safety profile with no new safety signals observed.

This additional approval for Breyanzi in Florida represents a crucial step in our mission to deliver the transformational promise of cell therapy to more patients across Europe, it said.

New LF therapies, such as Breyanzi, have shown impactful results in clinical trials, with the potential to deliver sustainable outcomes in routine care, it added.


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