# Ceritinib

Ceritinib (Zykadia, Novartis Europharm Limited) 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 | 1st line, advanced | - |
| ALK fusion | Monotherapy | 2nd line, advanced | Previously treated with crizotinib |

## Products

### Zykadia

- Company: Novartis Europharm Limited
- Target: ALK inhibitor
- Class: Anaplastic lymphoma kinase (ALK) inhibitors
- ATC: L01ED02
- EU approval: 6 May 2015
- Label revised: 29 Jan 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/zykadia-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/zykadia-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/zykadia

Mechanism (SmPC section 5.1): Ceritinib selectively inhibits autophosphorylation of ALK and downstream signalling, blocking proliferation of ALK-dependent cancer cells.

## Label wording

- **Ceritinib** (Zykadia), Non-small cell lung cancer, 1st line, advanced: “Zykadia as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zykadia-epar-product-information_en.pdf)
- **Ceritinib** (Zykadia), Non-small cell lung cancer, 2nd line, advanced: “Zykadia as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zykadia-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/ceritinib