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Oncologic Drugs Advisory Committee

On Wednesday, March 7, 2018 Oncologic Drugs Advisory Committee (ODAC) discussed and vote on the results from a supplemental biologics license application (sBLA) for Blincyto (blinatumomab) injection for intravenous (IV) use, submitted by Amgen, Inc. (Amgen). The proposed indication is the treatment of minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia. A majority of the Committee, 8 of 12 members, voted that the results of the pivotal clinical trial, MT103-203, demonstrate that for patients with acute lymphoblastic leukemia (ALL) in complete response (CR) who have minimal residual disease (MRD) > 0.1%, treatment with blinatumomab provides a potential benefit that outweighs the risks from the treatment.