Regulatory approval

Published by the Food and Drug Administration. Approved

VITRAKVI is a kinase inhibitor indicated 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. Select patients for therapy based on an FDA-approved test.

This is written in the approval document.

Citation

Loxo Oncology, Inc. Vitrakvi (larotrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210861s012lbl.pdf. Revised April 2025. Accessed April 30, 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	v::NTRK1	Any solid tumor	Larotrectinib
FDA (2)	v::NTRK2	Any solid tumor	Larotrectinib
FDA (2)	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.
2025-04-09	Food and Drug Administration	Indication received traditional approval.
2024-10-30	Van Allen lab	Initial access of FDA approvals
2018-11-26	Food and Drug Administration	Indication received accelerated approval.