Regulatory approval

Published by the Food and Drug Administration. Approved

BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

This is written in the approval document.

Citation

Amgen, Inc. Blincyto (blinatumomab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557Orig1s028Correctedlbl.pdf. Revised June 2024. Accessed October 30, 2024.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) CD19 + Acute Lymphoid Leukemia Blinatumomab