July hearing for pioneering CAR-T cell therapy

7 June 2017

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee will review the Biologics License Application (BLA) for CTL019 (tisagenlecleucel-T) in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia on July 12.

Swiss pharma giant Novartis (NOVN: VX) announced in March that the FDA had accepted for review the filing in this indication for CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, and granted priority review status.

Along with the likes of Kite Pharma (Nasdaq: KITE) and Juno Therapeutics (Nasdaq: JUNO), Novartis is leading the way in the emerging field of CAR-T investigational therapies.

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