Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that v::NTRK1 status confers therapeutic sensitivity to Entrectinib in patients with Any solid tumor.

Health Canada approved entrectinib 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 statement is based on a regulatory approval from the Health Canada:

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.

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.

Contributions

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