FDA Grants Breakthrough-Therapy Designation to CTL019 for Adult DLBCL

The U.S. Food and Drug Administration (FDA) has granted breakthrough-therapy designation to the investigational chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel-T, also known as CTL019, for treatment of adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Patients treated with CTL019 must have been failed by at least two prior therapies. The designation is based on interim results from the ongoing multicenter phase II JULIET study, which is evaluating the safety and efficacy of CTL019 in adults with DLBCL who have received at least two prior therapies.

The FDA previously granted breakthrough-therapy designation to CTL019 for relapsed or refractory B-cell acute lymphocytic leukemia.

Source: Novartis press release, April 18, 2017.