Table of contents
Xalkori is a cancer medicine used on its own to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the disease is advanced. It can be used if the NSCLC is ‘ALK-positive’, which means that the cancer cells contain certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase). It is also used when the NSCLC is ‘ROS1-positive’. This means that the cancer cells contain changes affecting the gene responsible for the protein ROS1.
Xalkori can also be used to treat children and adolescents from 6 to less than 18 years of age with ALK-positive anaplastic large cell lymphoma (ALCL), a type of blood cancer, or with ALK-positive inflammatory myofibroblastic tumour (IMT) that cannot be removed by surgery. IMT is a usually benign tumour affecting a type of muscle cells called myofibroblasts, which play an important role in the wound healing process.
Xalkori contains the active substance crizotinib.
Xalkori : EPAR - Summary for the public (PDF/119.15 KB)
First published: 14/11/2012
Last updated: 02/12/2022
Xalkori : EPAR - Risk management plan summary (PDF/86.87 KB)
First published: 02/12/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Carcinoma, Non-Small-Cell Lung
|Anatomical therapeutic chemical (ATC) code||
Pfizer Europe MA EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
Boulevard de la Plaine 17
28/10/2022 Xalkori - EMEA/H/C/002489 - II/0072
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
XALKORI as monotherapy is indicated for:
- The first‑line treatment of adults with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC)
- The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC)
- The treatment of adults with ROS1‑positive advanced non‑small cell lung cancer (NSCLC)
- The treatment of paediatric patients (age ≥6 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)‑positive anaplastic large cell lymphoma (ALCL)
- The treatment of paediatric patients (age ≥6 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK)‑positive unresectable inflammatory myofibroblastic tumour (IMT)