Regulatory approval

Published by the Health Canada. Approved

ROZLYTREK (entrectinib) is indicated for the treatment of adult patients with unresectable locally advanced or metastatic extracranial solid tumours, including brain metastases, that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, and with no satisfactory treatment options.

This is written in the approval document.

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::NTRK1	Any solid tumor	Entrectinib
HC (1)	v::NTRK2	Any solid tumor	Entrectinib
HC (1)	v::NTRK3	Any solid tumor	Entrectinib