Regulatory approval

Published by the European Medicines Agency. Approved

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 is written in the approval document as:

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.

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2019-09-19	European Medicines Agency	Indication received approval from the European Commission.