The Food and Drug Administration (FDA) granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics). Lisocabtagene maraleucel is a chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapies are a type of immunotherapy that involves engineering a patient’s T cells to recognize and attack cancer cells. Lisocabtagene maraleucel T cells are specifically designed to target CD19, a protein found on the surface of follicular lymphoma cells. Lisocabtagene maraleucel is approved for the treatment of adult patients with relapsed or refractory follicular lymphoma who have gone through two or more prior lines of systemic therapy.
Image Source: Vinoth Khandelwal
The approval was based on data from the TRANSCEND-FL (NCT04245839) trial, a Phase 2 study evaluating the efficacy and safety of lisocabtagene maraleucel in adults with relapsed or refractory follicular lymphoma who had received at least two prior lines of systemic therapy. The trial demonstrated an overall response rate (ORR) of 95.7% and a median duration of response (DOR) that was not reached after a median follow-up of 16.8 months. The most common side effects reported were cytokine release syndrome (CRS), headache, musculoskeletal pain, fatigue, constipation, and fever. Due to the risk of CRS and neurologic toxicities, lisocabtagene maraleucel is approved with a Risk Evaluation and Mitigation Strategy (REMS).
Lisocabtagene maraleucel offers a new treatment option for adults with relapsed or refractory follicular lymphoma who have exhausted other therapies. The FDA’s accelerated approval highlights the potential of this treatment approach, but long-term efficacy and safety data are still required.
Dr. Vinoth Khandelwal, Ph.D.
