Businesswire·2025-11-24 22:00Core Insights - Bristol Myers Squibb has received approval from the European Commission to expand the use of its CAR T cell therapy, Breyanzi, for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor [1][2][4] Group 1: Clinical Efficacy - In the TRANSCEND MCL trial, Breyanzi demonstrated an overall response rate of 82.7% and a complete response rate of 71.6% among patients treated in the third-line plus setting [2][3] - The therapy showed sustained clinical benefit, with 50.8% of patients still in response at 24 months [1][2] - The median time to first response was 0.95 months, indicating rapid efficacy [2] Group 2: Safety Profile - The safety results for Breyanzi were consistent with its established profile, with cytokine release syndrome (CRS) occurring in 61% of patients, and only 1% experiencing grade three or four CRS [3][19] - Neurologic toxicities were reported in 31% of patients, with grade three or four cases in 9% [3][19] - The majority of adverse events occurred within the first 14 days post-infusion, allowing for early resolution and adjustments to monitoring requirements [3] Group 3: Regulatory and Market Implications - This approval is applicable across all EU member states and EEA countries, marking the fourth approval for Breyanzi in Europe [4][5] - Breyanzi is also approved for other indications, including relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma [4][9] - Bristol Myers Squibb is positioned as a leader in cell therapy, with a focus on expanding treatment options for aggressive forms of non-Hodgkin lymphoma [34][36]