Annotation

Excerpts from the crizotinib (Xalkori) EPAR:

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

ALK testing An accurate and validated ALK assay is necessary for the selection of patients for treatment with XALKORI (see section 5.1 for information on assays used in the trials). Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised.

Crizotinib is a selective small-molecule inhibitor of the ALK receptor tyrosine kinase (RTK) and its oncogenic variants (i.e. ALK fusion events and selected ALK mutations).

This information is highlighted in the following sections:

Therapeutic indications, posology and method of administration, pharmacodynamic properties, obligation to conduct post-authorisation measures, package leaflet: information for the user.

For the complete drug label text with sections containing pharmacogenetic information, see the crizotinib EMA drug label.

*Disclaimer: The contents of this page have not been endorsed by the EMA and are the sole responsibility of PharmGKB.