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MAY 17, 2024

FDA Grants Accelerated Approval to Breyanzi for Follicular Lymphoma


Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

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