Annotation of Health Canada Santé Canada (HCSC) label information
for crizotinib
and ALK
Summary
The product monograph for crizotinib (XALKORI) states that it is indicated for patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer.
Annotation
Excerpts from the crizotinib (XALKORI) product monograph:
XALKORI (crizotinib) is indicated as monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).
The clinical benefit of XALKORI in patients with anaplastic lymphoma kinase (ALK)-negative NSCLC has not been established; therefore, XALKORI is not recommended for these patients.
ALK Testing. Prior to receiving therapy with XALKORI, patients must be tested and confirmed for ALK-positive locally advanced or metastatic NSCLC using a validated ALK assay...Assessment for ALK-positive locally advanced or metastatic NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilized.
Crizotinib is a selective small-molecule inhibitor of the Anaplastic Lymphoma Kinase (ALK) receptor tyrosine kinase (RTK) and its oncogenic variants (i.e., ALK fusion events and selected ALK mutations).
For the complete product monograph text with sections containing pharmacogenetic information highlighted, see the crizotinib product monograph.
*Disclaimer: The contents of this page have not been endorsed by HCSC and are the sole responsibility of PharmGKB.
