Regulatory approval
Published by the Health Canada.
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 is written in the approval document as:
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
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| 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 |