# Entrectinib

Entrectinib (Rozlytrek, Roche Registration GmbH ) has 2 EU-approved indications in 2 tumour types. Each needs a biomarker result: NTRK (1) and ROS1 (1).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| ROS1 fusion | Monotherapy | Advanced | No prior ROS1 inhibitor |

### Solid tumours, tumour-agnostic

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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 |

## Products

### Rozlytrek

- Company: Roche Registration GmbH 
- Target: TRK/ROS1/ALK inhibitor
- Class: Other protein kinase inhibitors
- ATC: L01EX14
- EU approval: 31 Jul 2020
- Label revised: 3 Nov 2026
- Status: conditional approval, PRIME
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/rozlytrek-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/rozlytrek-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/rozlytrek

Mechanism (SmPC section 5.1): Entrectinib inhibits the TRKA, TRKB, TRKC, ROS1 and ALK tyrosine kinases, blocking downstream signalling and cell proliferation driven by NTRK, ROS1 or ALK fusion proteins.

## 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)
- **Entrectinib** (Rozlytrek), Non-small cell lung cancer, advanced: “Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rozlytrek-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/entrectinib