Xalkori

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Questions & Answers

On 22 October 2015, 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 Limited.

The CHMP adopted a new indication as follows:

‘Xalkori is indicated for the first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)’.

For information, the full indications for Xalkori will be as follows:

‘Xalkori is indicated for the first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Xalkori is indicated for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC).’

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.

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Xalkori (English only) 2015-10-23  

Key facts

Product details for Xalkori
NameXalkori
INN or common name

crizotinib

Therapeutic area Carcinoma, Non-Small-Cell Lung
Active substance

crizotinib

Date opinion adopted22/10/2015
Company name

Pfizer Limited

StatusPositive
Application typePost authorisation