Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that FIP1L1::PDGFRA status confers therapeutic sensitivity to Imatinib in patients with Gastrointestinal Stromal Tumor.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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.