# Larotrectinib

Larotrectinib (Vitrakvi, Bayer AG) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: NTRK (1).

## Approved indications

### Solid tumours, tumour-agnostic

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |

## Products

### Vitrakvi

- Company: Bayer AG
- Target: Selective TRK inhibitor
- Class: Other protein kinase inhibitors
- ATC: L01EX12
- EU approval: 19 Sep 2019
- Label revised: 4 Aug 2026
- Status: conditional approval
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/vitrakvi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/vitrakvi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/vitrakvi

Mechanism (SmPC section 5.1): Larotrectinib is a selective ATP-competitive inhibitor of TRKA, TRKB and TRKC that blocks constitutive kinase activity of oncogenic TRK fusion proteins driving proliferation and survival.

## Label wording

- **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)

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/drugs/larotrectinib