
Novartis Receives FDA Priority Review for CAR-T Therapy
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
Priority review may shorten the FDA review process on Novartis’ BLA for CTL019, a big step for the Swiss biotech, which is currently
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