EMA Recommends Extension of Indications for Crizotinib

On 15 September 2022, the European Medicines Agency’s (EMA’s) 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 crizotinib (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 (new indications in bold):

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 ALK-positive advanced NSCLC
  • The treatment of adults with ROS1-positive advanced NSCLC
  • The treatment of paediatric patients (age ≥6 to <18 years) with relapsed or refractory systemic ALK-positive ALCL
  • The treatment of paediatric patients (age ≥6 to <18 years) with recurrent or refractory ALK‑positive unresectable IMT

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, 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.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.