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BMY Wins EC Nod for Label Expansion of CAR T Cell Therapy Breyanzi
ZACKS· 2025-11-25 20:06
Core Insights - Bristol Myers Squibb (BMY) received European Commission (EC) approval for Breyanzi (lisocabtagene maraleucel), expanding its label to include treatment 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 [2][10] - This marks the fourth approval for Breyanzi in Europe, which is already approved for several other lymphoma types [3][4] Approval Details - The latest EC approval is based on the MCL cohort results from the TRANSCEND NHL 001 trial, where 82.7% of patients responded to Breyanzi, and 71.6% achieved a complete response [5][10] - Sustained clinical benefits were observed, with 50.8% of patients remaining in response at 24 months [5][10] Pipeline Expansion - Bristol Myers is actively seeking to expand its pipeline due to the negative impact of generics on its legacy products like Revlimid, Pomalyst, Sprycel, and Abraxane [6] - The approval of new drugs and label expansions for existing drugs is expected to diversify its portfolio [6] Market Reaction - Shares of BMY increased by 3.3% following positive news from Bayer regarding its cardiovascular candidate asundexian, which met primary efficacy and safety endpoints in a late-stage study [7][9] - The success of Bayer's study has raised investor optimism for BMY's cardiovascular candidate, milvexian, in secondary stroke prevention [9] Study Discontinuation - Bristol Myers and Johnson & Johnson announced the discontinuation of the late-stage Librexia study for milvexian after an interim analysis indicated it was unlikely to meet primary efficacy endpoints [11] - However, two other late-stage studies for milvexian are set to continue, with top-line data expected in 2026 [12]