# Brigatinib

Brigatinib (Alunbrig, Takeda Pharma A/S) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: ALK (2).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| ALK fusion | Monotherapy | 2nd line, advanced | Previously treated with crizotinib |
| ALK fusion | Monotherapy | Advanced | No prior ALK inhibitor |

## Products

### Alunbrig

- Company: Takeda Pharma A/S
- Target: ALK and ROS1 tyrosine kinase inhibitor
- Class: Anaplastic lymphoma kinase (ALK) inhibitors
- ATC: L01ED04
- EU approval: 22 Nov 2018
- Label revised: 25 Apr 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/alunbrig-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/alunbrig-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/alunbrig

Mechanism (SmPC section 5.1): Tyrosine kinase inhibitor targeting ALK, ROS1, and IGF-1R that inhibits ALK autophosphorylation and downstream STAT3 signalling to suppress tumor cell growth.

## Label wording

- **Brigatinib** (Alunbrig), Non-small cell lung cancer, advanced: “Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/alunbrig-epar-product-information_en.pdf)
- **Brigatinib** (Alunbrig), Non-small cell lung cancer, 2nd line, advanced: “Alunbrig is indicated as monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/alunbrig-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/brigatinib