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Amgen Announces FDA Advisory Committee Meeting To Review Potential New Use Of BLINCYTO® (blinatumomab)

16:00 EST 14 Feb 2018 | AMGEN

First-Ever Application to be Submitted for an MRD Positive Indication THOUSAND OAKS, Calif., Feb. 14, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the BLINCYTO® (blinatumomab) supplemental Biologics License Application (sBLA) for the treatment of patients with minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (ALL) at a meeting on March 7, 2018. MRD refers to the presence of a small amount of detectible cancer cells that remain in the patient after treatment. "After achieving remission, the presence of MRD is the st...

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