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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	CD19 +	Acute Lymphoblastic Leukemia	Blinatumomab

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-06-14	Food and Drug Administration	Indication received traditional approval.