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Blinatumomab Approved in Europe for MRD+ ALL

Jason M. Broderick @jasoncology
Published: Tuesday, Jan 22, 2019

Dr. Nicola Gökbuget

Nicola Gökbuget, MD
The European Commission has approved blinatumomab (Blincyto) for the treatment of adult patients with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD) of at least 0.1%.

The FDA approved blinatumomab in March 2018 for adult and pediatric patients with MRD-positive ALL. Blinatumomab is also approved in the United States for the treatment of adult and pediatric patients with relapsed or refractory B-cell precursor ALL.
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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