🏅 Breyanzi wins EU nod for relapsed mantle cell lymphoma

The European Commission approved Breyanzi (lisocabtagene maraleucel) for relapsed/refractory mantle cell lymphoma after 2 prior therapies, based on Phase I TRANSCEND NHL 001 trial results.

Why It Matters To Oncology

▪ Breyanzi addresses a critical gap for MCL patients relapsing after BTK inhibitors, who typically face poor outcomes.

▪ TRANSCEND NHL 001 showed 82.7% overall response and 71.6% complete response rates, with durable responses at 24 months.

▪ Expands Breyanzi's reach across multiple aggressive B-cell lymphomas.

The Financials

▪ Breyanzi generated $747M in sales for BMS in 2023, reinforcing its growth potential.

What They're Saying

▪ Emma Charles, BMS SVP Europe: Breyanzi “has the opportunity to address a treatment gap for this patient population.”

What's Next

▪ BMS is pursuing approval in relapsed/refractory marginal zone lymphoma after positive TRANSCEND FL data (ORR 95.5%).

▪ FDA priority review decision is expected next month.