FDA Panel Backs Blinatumomab for MRD+ ALL

March 7, 2018 – Blinatumomab received an 8 to 4 vote from the FDA’s Oncologic Drugs Advisory Committee (ODAC) in favor of an indication for the treatment of minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (ALL). The FDA will now make its final decision on the blinatumomab indication, with an action date set under the Prescription Drug User Fee Act of March 29, 2018. At the meeting, ODAC was tasked with determining … (leggi tutto)