Regulatory approval

Published by the Health Canada. Approved

Health Canada approved entrectinib for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) not previously treated with crizotinib.

This is written in the approval document as:

ROZLYTREK (entrectinib) is indicated for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) not previously treated with crizotinib.

Citation

Hoffmann-La Roche Limited. Rozlytrek (entrectinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00073345.PDF. Revised November 2023. 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	Entrectinib

Contributions

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