Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that v::NTRK2 status confers therapeutic sensitivity to Larotrectinib in patients with Any solid tumor.

The European Medicines Agency (EMA) has conditionally authorized larotrectinib for the treatment of adult and pediatric patients with solid tumors that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion who have a disease that is locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity. It is also indicated for the treatment of adult and pediatric patients with solid tumors that display an NTRK gene fusion who have no satisfactory treatment options.

This statement is based on a regulatory approval from the European Medicines Agency:

VITRAKVI as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.

Citation

Bayer AG. Vitrakvi (larotrectinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/vitrakvi-epar-product-information_en.pdf. Revised September 2023. Accessed March 25, 2024.