Tag: acute lymphoblastic leukemia (ALL)

July 13, 2017 Off

Novartis’s drug gets recommendation for treating children with leukemia

By Dino Mustafić

The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).

March 30, 2017 Off

FDA accepts Novartis’s BLA for acute lymphoblastic leukemia treatment

By Dino Mustafić

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).