Bristol Myers Squibb (BMY) receives approval from the European Commission for the label expansion of Breyanzi, a CAR T cell therapy, for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two lines of therapy, including a BTK inhibitor. This marks the fourth approval for Breyanzi in Europe.

The approval is based on results from the MCL cohort of TRANSCEND NHL 001, showing 82.7% of patients responded to Breyanzi, with 71.6% achieving a complete response. Breyanzi demonstrated sustained clinical benefit, with 41.2% of patients still in response at 24 months. Bristol Myers aims to diversify its pipeline with new drugs and label expansions.

Shares of BMY rise 3.3% as Bayer’s pipeline candidate asundexian meets primary efficacy and safety endpoints in the OCEANIC-STROKE Study for secondary stroke prevention. Asundexian significantly reduces the risk of ischemic stroke compared to placebo in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. Bayer will seek marketing approvals worldwide.

BMY and JNJ discontinue the late-stage Librexia study for milvexian in acute coronary syndrome after an interim analysis showed unlikely meeting of primary endpoint. However, other studies for atrial fibrillation and secondary stroke prevention with milvexian will continue as planned. Top-line data from these studies expected in 2026.

Read more at Nasdaq: BMY Wins EC Nod for Label Expansion of CAR T Cell Therapy Breyanzi (Revised)