Basic Information
Xalkori
Regulatory Information
EMEA/H/C/002489
October 23, 2012
July 19, 2012
37
February 27, 2025
Company Information
Belgium
Boulevard de la Plaine 17 1050 Bruxelles
Pfizer Europe MA EEIG
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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 1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL) \- The treatment of paediatric patients (age 1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK) positive unresectable inflammatory myofibroblastic tumour (IMT)
Overview Summary
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 1 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.