Regulatory approval

Published by the Food and Drug Administration. Approved

Gleevec is a kinase inhibitor indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.

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
Organizations Biomarkers Cancer types Therapies
FDA (2) PDGFRA rearrangements Myelodysplastic Syndromes Imatinib
FDA (2) PDGFRB rearrangements Myelodysplastic Syndromes Imatinib

Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals
2006-10-19 Food and Drug Administration Indication received traditional approval.