Novartis Receives FDA Priority Review for CAR-T Therapy

On March 29, 2017 Novartis announced that CTL019 (tisagenlecleucel-T), its investigational chimeric antigen receptor T-cell (CAR-T) therapy, has been accepted for priority review by FDA. CTL019 is intended to treat pediatric and young adult patients with B-cell acute lymphoblastic leukemia.

Novartis’ biologics license application (BLA) submission is based on data from its Phase II ELIANA trial. The CAR-T therapy demonstrated an 82% (41 out of 50) complete remission rate in patients during Phase II trials, Novartis reported. The company also said 48% of patients in the trial demonstrated grade 3 or 4 cytokine release syndrome (CRS), a known complication of CAR-T therapies that can be fatal. In a statement, Novartis noted no patients died due to CRS, although 15% did experience grade 3 neurological and psychological events.

Priority review may shorten the FDA review process on Novartis’ BLA for CTL019, a big step for the Swiss biotech, which is currently competing with Kite Pharma to nab the first FDA approval for a CAR-T therapy. Axicabtagene ciloleucel (KTE-C19), Kite’s CAR-T therapy, is under investigation for aggressive non-Hodgkin Lymphoma. Kite previously said it plans to file for FDA approval in the first quarter of 2017.