Regulatory approval

Published by the Health Canada.

Health Canada approved imatinib mesylate 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 as:

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.

Citation

Novartis Pharmaceuticals Canada Inc. Gleevec (imatinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00067276.PDF. Revised August 2021. Accessed June 2025.

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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 (+) KIT p.D816V Aggressive Systemic Mastocytosis Imatinib