Posted by Michael Wonder on 15 May 2024
FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma
15 May 2024 - Today, the FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for adults with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy.
Efficacy was evaluated in TRANSCEND-FL, a Phase 2, open-label, multi-centre, single-arm trial in adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy (including an anti-CD20 antibody and an alkylating agent).
