Regulatory approval

Published by the Food and Drug Administration. Approved

Gleevec is a kinase inhibitor indicated for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

This is written in the approval document.

Citation

Novartis Pharmaceuticals Corporation. Gleevec (imatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021588s062lbl.pdf. Revised August 2022. 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) BCR::ABL1 Chronic Myelogenous Leukemia Imatinib
FDA (1) BCR::ABL1 Chronic Myeloid Leukemia, BCR-ABL1+ Imatinib