# Repotrectinib

Repotrectinib (Augtyro, Bristol-Myers Squibb Pharma EEIG) 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 | - |

### Solid tumours, tumour-agnostic

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

## Products

### Augtyro

- Company: Bristol-Myers Squibb Pharma EEIG
- Target: ROS1 and TRK tyrosine kinase inhibitor
- Class: Other protein kinase inhibitors
- ATC: L01EX28
- EU approval: 13 Jan 2025
- Label revised: 28 Jan 2025
- Status: conditional approval
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/augtyro-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/augtyro-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/augtyro

Mechanism (SmPC section 5.1): Binds the ATP-binding pocket of ROS1, TRKA/B/C and ALK and inhibits these kinases, including solvent-front and gatekeeper resistance mutants, blocking fusion-driven signalling and proliferation.

## Label wording

- **Repotrectinib** (Augtyro), Non-small cell lung cancer, advanced: “AUGTYRO as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/augtyro-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/drugs/repotrectinib