BMS' Breyanzi CAR-T Therapy Approved for Treating Mantle Cell Lymphoma | iPharmaCenter

Bristol Myers Squibb (BMS) has received European Commission approval to extend the use of its CAR T cell therapy Breyanzi (lisocabtagene maraleucel, liso-cel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL). This approval covers patients who have previously undergone at least two systemic treatments, including a Bruton’s tyrosine kinase (BTK) inhibitor.

The positive decision is founded on data from the TRANSCEND NHL 001 trial, where Breyanzi showed an impressive overall response rate of 82.7%, and a complete response rate of 71.6%. Breyanzi demonstrated durable clinical benefit, with 41.2% of patients maintaining response at 24 months, according to results from the TRANSCEND MCL trial.

Safety findings align with Breyanzi’s established profile, with cytokine release syndrome (CRS) reported in 61% of patients but severe cases limited to 1%. Neurologic side effects were observed in 31% of patients, including 9% with severe manifestations. Most adverse events occurred within the first two weeks after treatment, supporting recent recommendations for monitoring.

The approval applies across all European Union member countries and European Economic Area (EEA) nations Iceland, Norway, and Liechtenstein. Breyanzi is already authorized in Europe for various other relapsed or refractory large B-cell lymphomas and follicular lymphoma subtypes, providing an advanced immunotherapy option for aggressive B-cell cancers.

TRANSCEND NHL 001 is a pivotal, open-label Phase 1 trial evaluating Breyanzi’s efficacy and safety in multiple B-cell non-Hodgkin lymphoma types, including MCL, diffuse large B-cell lymphoma, and follicular lymphoma grade 3B. Key endpoints include overall response and progression-free survival.

This expanded EMA approval marks a significant milestone for BMS in broadening patient access to innovative CAR T therapies designed to improve outcomes in aggressive lymphoma cases with limited treatment options.