# Crizotinib

Crizotinib (Xalkori, Pfizer Europe MA EEIG) has 5 EU-approved indications in 3 tumour types. Each needs a biomarker result: ALK (4) and ROS1 (1).

## 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 |
| ROS1 fusion | Monotherapy | Advanced | - |

### T-cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| ALK fusion | Monotherapy | 2nd line | Systemic ALCL only; Children and adolescents only; Relapsed or refractory; Age ≥ 1 to < 18 years |

### Other musculoskeletal tumours

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| ALK fusion | Monotherapy | 2nd line, advanced | Children and adolescents only; Recurrent or refractory; Age ≥ 1 to < 18 years |

## Products

### Xalkori

- Company: Pfizer Europe MA EEIG
- Target: ALK/ROS1/MET tyrosine kinase inhibitor
- Class: Anaplastic lymphoma kinase (ALK) inhibitors
- ATC: L01ED01
- EU approval: 23 Oct 2012
- Label revised: 17 Sep 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/xalkori-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/xalkori

Mechanism (SmPC section 5.1): Small-molecule inhibitor of the ALK tyrosine kinase and its oncogenic fusions/mutations, and of ROS1, c-Met and RON kinases, blocking their phosphorylation to inhibit tumour growth and induce apoptosis.

## Label wording

- **Crizotinib** (Xalkori), Non-small cell lung cancer, 1st line, advanced: “The first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf)
- **Crizotinib** (Xalkori), Non-small cell lung cancer, 2nd line, advanced: “The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf)
- **Crizotinib** (Xalkori), Non-small cell lung cancer, advanced: “The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf)
- **Crizotinib** (Xalkori), T-cell lymphoma, 2nd line: “The treatment of paediatric patients (age ≥1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf)
- **Crizotinib** (Xalkori), Other musculoskeletal tumours, 2nd line, advanced: “The treatment of paediatric patients (age ≥1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK)-positive unresectable inflammatory myofibroblastic tumour (IMT)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xalkori-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/crizotinib