Xalkori

RSS

crizotinib

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 02/12/2022

Authorisation details

Product details
Name
Xalkori
Agency product number
EMEA/H/C/002489
Active substance
crizotinib
International non-proprietary name (INN) or common name
crizotinib
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01ED01
Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
33
Date of issue of marketing authorisation valid throughout the European Union
23/10/2012
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

28/10/2022 Xalkori - EMEA/H/C/002489 - II/0072

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Product information documents contain:

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.

Pharmacotherapeutic group

Antineoplastic agents

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 ≥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)

Assessment history

Changes since initial authorisation of medicine

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