FDA Grants Priority Review to CAR T-Cell Therapy for DLBCL

The FDA granted priority review to the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel for adults with relapsed/refractory diffuse large B-cell lymphoma who are ineligible for or have relapsed after autologous hematopoietic cell transplantation. Tisagenlecleucel is already approved for the treatment of children and young adults with relapsed or refractory B-cell acute lymphocytic leukemia.

The submission is based on data from the phase II JULIET study, in which a single infusion of tisagenlecleucel led to an ORR of 53 percent, with 40 percent of patients achieving a complete response. For 46 participants with at least six months of follow-up from infusion, the ORR was 37 percent, with a complete response rate of 30 percent and a partial response rate of 7 percent.

Sources: Reuters, January 17, 2018; Schuster SJ, Bishop MR, Tam CS, et al. Primary analysis of Juliet: a global, pivotal, phase 2 trial of CTL019 in adult patients with relapsed or refractory diffuse large B-cell lymphoma. Abstract #577. Presented at the 2017 American Society of Hematology Annual Meeting, December 11, 2017; Atlanta, GA.