# NTRK

3 EU-approved indications of 3 drugs need a NTRK result, in 1 tumour type, most of them in solid tumours, tumour-agnostic.

## Approved indications by tumour

### Solid tumours, tumour-agnostic

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

## Label wording

- **Entrectinib** (Rozlytrek), Solid tumours, tumour-agnostic, any line: “Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients older than 1 month with solid tumours that have a 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 not received a prior NTRK inhibitor  who have no satisfactory treatment options (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rozlytrek-epar-product-information_en.pdf)
- **Larotrectinib** (Vitrakvi), Solid tumours, tumour-agnostic, any line: “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 (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vitrakvi-epar-product-information_en.pdf)
- **Repotrectinib** (Augtyro), Solid tumours, tumour-agnostic, advanced: “AUGTYRO as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and  who have received a prior NTRK inhibitor, or  have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/augtyro-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/biomarkers/ntrk