Novartis Receives FDA Priority Review for CAR-T Therapy

March 30, 2017
Caroline Hroncich

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

The company received priority review for its investigational CAR-T therapy to treat leukemia.

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.

Source: Novartis