Xalkori

crizotinib

Opinion

On 15 September 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xalkori. The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.

The CHMP adopted 2 new indications for the treatment of paediatric patients with anaplastic large cell lymphoma (ALCL) or inflammatory myofibroblastic tumour (IMT). For information, the full indications for Xalkori will therefore be as follows:1

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)

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold

Key facts

Name
Xalkori
Agency product number
EMEA/H/C/002489
International non-proprietary name (INN) or common name
  • crizotinib
Active substance
  • crizotinib
Therapeutic area
Carcinoma, Non-Small-Cell Lung
Date opinion adopted
15/09/2022
Company name
Pfizer Europe MA EEIG
Status
Positive
Application type
Post-authorisation

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