FDA Grants Accelerated Approval to Breyanzi for Follicular Lymphoma

The FDA has granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.

Efficacy was evaluated in TRANSCEND-FL (ClinicalTrials.gov Identifier: NCT04245839), a phase 2, open-label, multicenter, single-arm trial in adults with relapsed or refractory FL after two or more lines of systemic therapy, including an anti-CD20 antibody and alkylating