FDA record shows two 2024 Breyanzi approvals in lymphoma, one accelerated, one full

FDA records on file show two separate 2024 approvals for lisocabtagene maraleucel, sold as Breyanzi by Juno Therapeutics, Inc.

The earlier action came first. On May 15, 2024, the Food and Drug Administration granted accelerated approval to lisocabtagene maraleucel for adults with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy.¹

Two weeks later, the agency issued a separate, full approval for a different lymphoma type. On May 30, 2024, the Food and Drug Administration approved lisocabtagene maraleucel for adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.²

The two FDA records provided do not include further detail on trial results, dosing information, or any subsequent regulatory milestones beyond the indications and approval dates stated above. Readthrough will note any further developments as they are confirmed in primary source documents.