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# FDA Panel Backs Novartis CAR-T Cell Therapy
- URL: https://www.fdaweb.com/fda-panel-backs-novartis-car-t-cell-therapy/
- Published: 2017-07-13T12:00:00.000Z
- Updated: 2026-09-14T22:34:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139126

FDA’s Oncologic Drugs Advisory Committee has voted 10-0 to support approval of a Novartis BLA for CTL019 (tisagenlecleucel-T), a chimeric antigen receptor T-cell (CAR-T) for treating pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. CAR-T therapies are different from traditional drug or biologic therapies because they are manufactured for each individual patient using their own cells. “During the treatment process, T cells are drawn from a patient's blood and reprogrammed in the manufacturing facility to create T cells that are genetically coded to express a chimeric antigen receptor to recognize and fight cancer cells and other B-cells expressing a specific antigen,” according to the company.

The panel’s recommendation was based on data from is the Novartis-led ELIANA study, which it described as the first pediatric global CAR-T cell therapy registration trial. Data showed that 83% of CTL019-treated patients achieved complete remission or complete remission with incomplete blood count recovery at three months post-infusion. The therapy comes with some safety risks, such as cytokine release syndrome. Several panel members said the benefits outweighed the risks and that a risk evaluation and mitigation strategy could offset the risks.

  
Some panel members also raised concern with Novartis’ manufacturing process. After the meeting, the company said it has confidence in its leukapheresis process using cryopreservation, which involves removing white cells from a patient’s blood and preserving them at very low temperatures. “Cryopreserved leukapheresis gives physicians the flexibility to schedule apheresis at a time that is in the best interest of their patients,” it said. “Novartis commercial manufacturing for CTL019 continues to build on its experience in its Morris Plains, NJ facility, which has already manufactured CTL019 for hundreds of patients in global clinical trials. Novartis believes that experience is important in cell therapy manufacturing, and the experience gained at the Morris Plains, NJ facility will be a foundation for commercial manufacturing of CAR-T therapies. Novartis has made and continues to make investments in manufacturing.”