Regulatory approval

Published by the Health Canada. Approved

VITRAKVI (larotrectinib) is indicated for the treatment of adult and pediatric patients with solid tumours that have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation.

This is written in the approval document.

Citation

Bayer Inc. Vitrakvi (larotrectinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00076917.PDF. Revised September 2024. 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	Larotrectinib
HC (1)	v::NTRK2	Any solid tumor	Larotrectinib
HC (1)	v::NTRK3	Any solid tumor	Larotrectinib

Contributions

Date	Contributor	Description
2025-04-30	Van Allen lab	The FDA provided regular approval to larotrectinib for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
2024-10-30	Van Allen lab	Initial access of FDA approvals