Vitrakvi (larotrectinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

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

Indication	Statements
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.	3

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