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Amgen's MRD+ ALL therapy recommended by FDA panel

The FDA's Oncologic Drugs Advisory Committee has voted 8-4 in favor of the use of Amgen's Blincyto, or blinatumomab, as a treatment for patients with minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia. The supplemental biologics license application was backed by data from a midstage study, in which 69 of 116 patients in the study achieved a complete MRD response within the first cycle of blinatumomab treatment.

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