Biotech investors will be marking July 12 on their calendars as this is the day of the FDA advisory committee review of Novartis’ (NVS) Biologics License Application (BLA) seeking approval of Breakthrough Therapy-tagged CTL019 (tisagenlecleucel-T), a CAR-T candidate for the treatment of pediatric and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia. The FDA accepted the BLA under Priority Review status which shortens the review clock to six months so the action date should be in late September.
