March 30, 2017
FDA accepts Novartis’s BLA for acute lymphoblastic leukemia treatment
US Food and Drug Administration (FDA) has accepted the Novertis’s 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).