BMS's Breyanzi CAR-T gets fast-track approval for follicular lymphoma

The FDA granted accelerated approval on Wednesday to Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) who have undergone at least two prior lines of systemic therapy. This marks the second time this year that the CD19-targeting CAR-T cell therapy has had its label expanded, with further expansion anticipated before the end of the month. The FDA is currently reviewing another application for Breyanzi to treat relapsed or refractory mantle cell lymphoma (MCL), with a decision expected by May 31.

Earlier in March, Breyanzi received approval as the first CAR-T therapy for relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), establishing it as a viable option when traditional treatments fail. This approval has solidified Breyanzi's role in the treatment landscape for these conditions. The cell therapy was initially authorized in the United States in 2021 for third-line treatment of large B-cell lymphoma.

Wednesday’s approval was influenced by findings from the Phase II TRANSCEND-FL study. In this clinical trial, Breyanzi exhibited an overall response rate of 95.7% among 94 FL patients. Notably, the median duration of response was not reached even after a follow-up period of 16.8 months, indicating sustained effectiveness.