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FDA Grants Tisagenlecleucel Priority Review for DLBCL

Jason M. Broderick @jasoncology
Published: Wednesday, Jan 17, 2018

Samit Hirawat, executive vice president and head, Global Drug Development at Novartis Oncology
Samit Hirawat
The FDA has granted a priority review to a supplemental biologics license application (sBLA) for the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) for use in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT). 

The overall remission rate was 82.5% (95% CI, 70.9-91.0) in treated subjects. Forty patients (63%) had CR and 12 (19%) had CR with incomplete hematologic recovery.
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. Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2017; Atlanta. Abstract 577.

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