Lisocabtagene maraleucel receives FDA approval for the second-line treatment of large B-cell lymphoma

On June 24, 2022, it was announced that the U.S. Food and Drug Administration (FDA) had granted approval to lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell product, for the treatment of relapsed or refractory large B-cell lymphoma in adult patients who have already received ≥1 line of systemic therapy. The approval is based on key data obtained from the phase III TRANSFORM and phase II PILOT studies (NCT03575351; NCT03483103). ¹

The approval encompasses patients with diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma Grade 3B, who have:

• Disease that is refractory to first-line chemoimmunotherapy or relapses within 1 year of first-line chemoimmunotherapy; or
• Disease that is refractory to first-line chemoimmunotherapy or relapses after first-line chemoimmunotherapy that is not eligible for hematopoietic stem cell transplant.

Liso-cel has demonstrated deep and durable responses in these patient groups, while also exhibiting a tolerable safety profile. The approval comes shortly after news of the European Commission approval of liso-cel for the ≥3rd line treatment of certain forms of relapsed or refractory large B-cell lymphoma, as previously reported on the Lymphoma Hub.