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)||23/10/2015|
|INN or common name|
|Therapeutic area||Carcinoma, Non-Small-Cell Lung|
|Date opinion adopted||22/10/2015|
|Application type||Post authorisation|