Regulatory approval

Published by the Health Canada. Approved

Health Canada approved repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

This is written in the approval document as:

AUGTYRO (repotrectinib capsules) is indicated for treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Citation

Bristol-Myers Squibb Canada. Augtyro (repotrectinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00080483.PDF. Published May 2024. Accessed June 2025.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	v::ROS1	Non-Small Cell Lung Cancer	Repotrectinib

Contributions

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