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FDA Schedules ODAC Hearing for Tisagenlecleucel-T for Relapsed/Refractory B-cell ALL

Jason Harris
Published: Tuesday, Jun 06, 2017

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has scheduled a public hearing for July 12, 2017, to discuss a biologics license application (BLA) for tisagenlecleucel-T (CTL019) for patients aged 3 to 25 years with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL).

Novartis has announced plans to request FDA approval for tisagenlecleucel-T as a treatment for relapsed/refractory diffuse large B-cell lymphoma by the end of this year. The company also plans to apply for regulatory approval in Europe.
Grupp SA, Laetsch TW, Buechner J, et al. Analysis of a global registration trial of the efficacy and safety of CTL019 in pediatric and young adults with relapsed/refractory acute lymphoblastic leukemia. 58th ASH Annual Meeting and Exposition; San Diego, California; December 2-6, 2016. Abstract 221.

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