- 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.
- A positive vote by the committee and regulatory approval will be a big milestone for the company and other CAR-T developers like Kite Pharma (KITE +2.3%) and Juno Therapeutics (JUNO +2.5%). Kite completed its BLA filing for KTE-C19 (axicabtagene ciloleucel) in late March. In late May, the agency accepted the filling, also under Priority Review, with an action date of November 29.
- Previously: FDA accepts Novartis' BLA for CAR-T candidate CTL019 under accelerated review (March 29)
- Previously: Kite's BLA for lead product candidate gets accelerated review from FDA, action date November 29 (May 26)
- Now read: What's Ahead For CAR-T Play Kite Pharma?
Original article