Regulatory approval

Published by the Health Canada. Approved

GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with aggressive sub-types of systemic mastocytosis (ASM and SMAHNMD) without the D816V c-Kit mutation.

This is written in the approval document.

Citation

Novartis Pharmaceuticals Canada Inc. Gleevec (imatinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00083190.PDF. Revised January 2026. Accessed April 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	not KIT p.D816V	Aggressive Systemic Mastocytosis	Imatinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals