FDA Schedules ODAC Hearing for Tisagenlecleucel-T for Relapsed/Refractory B-cell ALL

June 6, 2017 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) has scheduled a public hearing for July 12, 2017, to discuss a biologics license application (BLA) for tisagenlecleucel-T (CTL019) for patients aged 3 to 25 years with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). Tisagenlecleucel-T became the first CAR T cell therapy to go into regulatory review when it won priority review status from the FDA in March. Under the priority review … (leggi tutto)