Vitrakvi (larotrectinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::NTRK1	Any solid tumor	Larotrectinib
Sensitivity (+)	v::NTRK2	Any solid tumor	Larotrectinib
Sensitivity (+)	v::NTRK3	Any solid tumor	Larotrectinib