Rozlytrek (entrectinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	3
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::NTRK1	Any solid tumor	Entrectinib
Sensitivity (+)	v::NTRK2	Any solid tumor	Entrectinib
Sensitivity (+)	v::NTRK3	Any solid tumor	Entrectinib
Sensitivity (+)	v::ROS1	Non-Small Cell Lung Cancer	Entrectinib