Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that not KIT p.D816V status confers therapeutic sensitivity to Imatinib in patients with Aggressive Systemic Mastocytosis.

The U.S. Food and Drug Administration granted approval to imatinib for the treatment of adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.

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

Gleevec is a kinase inhibitor indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.

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. Novartis Pharmaceuticals Corporation. Gleevec (imatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf. Revised October 2006. Accessed October 6, 2026.

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.