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.

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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