FDA Approves New Indications for Liso-Cel CAR T-Cell Therapy

The Food and Drug Administration approved two new indications for lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, last week. Liso-cel (Breyanzi, Juno Therapeutics—a Bristol Myers Squibb company) is approved for the treatment of adult patients with previously treated large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified; high-grade B-cell lymphoma; primary mediastinal large B-cell lymphoma; and follicular lymphoma grade 3B.

Patients who have refractory disease after first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy are now eligible for the treatment, as are patients with relapsed or refractory illness after first-line chemoimmunotherapy who are not eligible for hematopoietic stem cell transplant (HSCT) due to comorbidities or age.

FDA first approved liso-cel for patients with relapsed or refractory disease after two or more lines of systemic therapy in February 2021. FDA approved the therapy with a risk evaluation and mitigation strategy (REMS) that includes elements to assure safe use. Additional information is available on FDA’s Cellular and Gene Therapy Products web page.