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.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
FDA (1) v::NTRK1 Any solid tumor Larotrectinib
FDA (1) v::NTRK2 Any solid tumor Larotrectinib
FDA (1) v::NTRK3 Any solid tumor Larotrectinib