FDA Expands Approval for CAR T-Cell Therapy

The U.S. Food and Drug Administration expanded the approval of the chimeric antigen receptor T-cell therapy tisagenlecleucel to include patients with relapsed/refractory large B-cell lymphoma, high-grade B-cell lymphoma, or diffuse large B-cell lymphoma arising from follicular lymphoma who received two or more lines of systemic therapy.

The decision was based on results from the pivotal, multicenter, global, phase II JULIET study. Among 68 evaluable patients, the response rate was 50% (95% CI 38-62), the complete response rate was 32%, and the partial response rate was 18%. The median duration of response had not been reached.

Twenty-three percent of patients developed grade 3 or grade 4 cytokine release syndrome, 18% experienced grade 3 or grade 4 neurologic events, and 11% experienced severe or life-threatening encephalopathy.

Source: Healio