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FDA Approves Amgen’s Blincyto for Acute Lymphoblastic Leukemia

For patients with minimal residual disease at baseline after remission.

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By: Kristin Brooks

Managing Editor, Contract Pharma

The U.S. FDA has approved the supplemental Biologics License Application (sBLA) for Amgen’s BLINCYTO (blinatumomab) for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD), based on additional data from two Phase 3 studies. The approval converts BLINCYTO’s accelerated approval to a full approval. Amgen continues to advance its development program ...

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