Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that v::NTRK3 status confers therapeutic sensitivity to Larotrectinib in patients with Any solid tumor.

The U.S. Food and Drug Administration granted 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. Larotrectinib's product label specifies to select patients for therapy based on an FDA-approved test.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

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. Loxo Oncology, Inc. Vitrakvi (larotrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210861s000lbl.pdf. Revised November 2018. Accessed October 6, 2026.

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.