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
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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).
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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)