Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Therapeutic response

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

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