FDA Approves Liso-Cel for Relapsed or Refractory MCL

The Food and Drug Administration approved lisocabtagene maraleucel (liso-cel) for the treatment of certain adult patients with relapsed or refractory mantle cell lymphoma (MCL) May 31. This marks the fourth FDA-approved indication for liso-cel, which is marketed as Breyanzi by Bristol Myers Squib.

FDA based its decision on findings from the TRANSCEND NHL 001 trial, which included 68 patients with MCL who received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. The overall response rate was 85.3% and the complete response rate was 67.6%. After a median follow-up of 22.2 months, the median duration of response was 13.3 months.

Liso-cel comes with a boxed warning for cytokine release syndrome, neurologic toxicities and secondary hematological malignancies. The approval includes a risk evaluation and mitigation strategy (REMS) with elements to assure safe use. Additional information is available on FDA’s Cellular and Gene Therapy Products web page.