Novartis CAR-T cell therapy BLA accepted for FDA priority review

The US Food and Drug Administration has accepted the Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).

This is the first BLA submission by Swiss pharma giant Novartis (NOVN: VX) for a CAR-T. The priority review designation is expected to shorten the anticipated review time by the FDA.

CAR-T is different from typical small-molecule or biologic therapies currently on the market because it is manufactured for each individual patient. During the treatment process, T cells are drawn from a patient's blood and reprogrammed in the laboratory to create T cells that are genetically coded to hunt the patient's cancer cells and other B-cells expressing a particular antigen.