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Bristol Myers Squibb’s Breyanzi® Receives CHMP Recommendation for Relapsed or Refractory Follicular Lymphoma in the EU

NextEdge Admin

01 Feb 2025

2 min 55 sec

Bristol Myers Squibb 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 adult patients with relapsed or refractory follicular lymphoma (FL) after two or more prior lines of systemic therapy. The European Commission (EC) will now review this recommendation for potential approval across the European Union (EU).

Anne Kerber, Senior Vice President of Hematology, Oncology, and Cell Therapy at Bristol Myers Squibb, highlighted the company’s commitment to advancing CAR T cell therapies, especially for difficult-to-treat cancers like relapsed or refractory FL, which remains incurable.

The CHMP recommendation is based on results from the Phase 2 TRANSCEND FL study, the largest trial of a CAR T cell therapy in relapsed or refractory indolent non-Hodgkin lymphoma (NHL). Breyanzi demonstrated a 97.1% overall response rate and a 94.2% complete response rate. Responses were rapid and durable, with 75.7% of patients still in response at 18 months. The safety profile was consistent with prior studies, with no new safety concerns identified.

FL is a slow-growing NHL subtype with cycles of remission and relapse. Despite treatment advancements, relapsed or refractory FL remains an area of high unmet need, particularly for the 20% of patients who relapse within two years of first-line therapy. CAR T cell therapies have shown promise in delivering durable responses with manageable safety profiles.

The EC typically makes a final decision within two months of a CHMP recommendation, extending approval to all EU member states and EEA countries.

Breyanzi is already approved in the EU for other relapsed or refractory B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBCL). Bristol Myers Squibb acknowledges the patients and investigators involved in the TRANSCEND FL study.