Regulatory approval

Published by the Food and Drug Administration.

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 is written in the approval document as:

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.

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