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FDA Approves Blinatumomab for MRD+ ALL

Jason M. Broderick @jasoncology
Published: Thursday, Mar 29, 2018

Richard Pazdur, MD

Richard Pazdur, MD
The FDA has granted an accelerated approval to blinatumomab (Blincyto) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD).

Blinatumomab was previously approved by the FDA for the treatment of adult and pediatric patients with relapsed or refractory B-cell precursor ALL. The accelerated approval of blinatumomab for MRD-positive is contingent upon confirmatory results from future studies.
FDA Briefing Document Oncologic Drugs Advisory Committee Meeting BLA 125557 S-013 Blincyto (blinatumomab) Applicant: Amgen, Inc. Published Accessed March 29, 2018.

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