# Alectinib

Alectinib (Alecensa, Roche Registration GmbH) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: ALK (3).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| ALK fusion | Monotherapy | Adjuvant | After complete tumour resection; High risk of recurrence |
| ALK fusion | Monotherapy | 1st line, advanced | - |
| ALK fusion | Monotherapy | 2nd line, advanced | Previously treated with crizotinib |

## Products

### Alecensa

- Company: Roche Registration GmbH
- Target: ALK and RET kinase inhibitor
- Class: Anaplastic lymphoma kinase (ALK) inhibitors
- ATC: L01ED03
- EU approval: 16 Feb 2017
- Label revised: 31 Mar 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/alecensa-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/alecensa

Mechanism (SmPC section 5.1): Alectinib selectively inhibits ALK and RET tyrosine kinases, blocking downstream STAT3 and PI3K/AKT signalling pathways and inducing tumour cell death.

## Label wording

- **Alectinib** (Alecensa), Non-small cell lung cancer, adjuvant: “Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK-positive NSCLC at high risk of recurrence (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf)
- **Alectinib** (Alecensa), Non-small cell lung cancer, 1st line, advanced: “Alecensa as monotherapy is indicated for the first-line treatment of adult patients with ALK-positive advanced NSCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf)
- **Alectinib** (Alecensa), Non-small cell lung cancer, 2nd line, advanced: “Alecensa as monotherapy is indicated 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/alecensa-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/alectinib