FDA Panel to Review Blinatumomab Application for MRD-positive ALL

February 15, 2018 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) is slated to review a supplemental biologics license application (sBLA) for the use of blinatumomab for the treatment of patients with minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (ALL). The ODAC meeting is scheduled for March 7. A Prescription Drug User Fee Act target action date for the sBLA has been set for March 29. Amgen filed the sBLA for … (leggi tutto)