FDA approves new indication for CAR T-cell therapy to be use in adults with relapsed/refractory Large B-Cell lymphoma
The FDA has approved tisagenlecleucel – CART T-cell
therapy- (Kymriah) for use in adult patients with relapsed/refractory large
B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade
B-cell lymphoma and DLBCL arising from follicular lymphoma—after 2 or more
lines of systemic therapy.
The approval is based on the phase II JULIET study, in which the CD19-directed chimeric antigen receptor (CAR) T-cell therapy reached an overall response rate (ORR) of 50% (95% CI, 38%-62%) in adult patients with relapsed/refractory DLBCL. The complete response (CR) rate was 32% and the partial response rate was 18%. The median duration of response had not been reached.
The approval is based on the phase II JULIET study, in which the CD19-directed chimeric antigen receptor (CAR) T-cell therapy reached an overall response rate (ORR) of 50% (95% CI, 38%-62%) in adult patients with relapsed/refractory DLBCL. The complete response (CR) rate was 32% and the partial response rate was 18%. The median duration of response had not been reached.
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