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# FDA Priority Review for Novartis CAR-T Therapy
- URL: https://www.fdaweb.com/fda-priority-review-for-novartis-car-t-therapy/
- Published: 2017-03-31T12:00:00.000Z
- Updated: 2026-09-14T22:15:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138350

FDA has accepted for priority review a Novartis BLA for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for use in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia. CAR-T therapies are manufactured for each individual patient by drawing T-cells from the blood and reprogramming them in the laboratory to create T cells that are genetically coded to hunt cancer cells and other B-cells expressing a particular antigen, according to the company. CTL019 was first developed by the University of Pennsylvania and is now licensed to Novartis under a research collaboration.

  
Novartis says the priority review designation is based on results from the ELIANA study. Data showed that 82% (41 of 50) of patients infused with CAR-T cells achieved complete remission or complete remission with incomplete blood count recovery at three months post CTL019 infusion. “Forty-eight percent of patients in the ELIANA trial experienced grade 3 or 4 cytokine release syndrome (CRS), a known complication of an investigational therapy that may occur when the engineered cells become activated in the patient’s body,” the company says.