Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to imatinib for the adjuvant treatment of adult patients following resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST).

This is written in the approval document as:

Gleevec is a kinase inhibitor indicated for the adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST.

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.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) FIP1L1::PDGFRA Gastrointestinal Stromal Tumor Imatinib