Annotation of Pharmaceuticals and Medical Devices Agency, Japan (PMDA) label information
for crizotinib and ALK

Testing required

Summary

Crizotinib is indicated for the treatment of patients with non-small cell lung cancer. The PMDA package insert for crizotinib states positive confirmation of the ALK fusion gene is necessary prior to treatment.

Annotation

Please note that the information contained within this drug label annotation is available through a collaboration with the Japanese Society of Pharmacogenomics, who provided a translation of the pharmacogenetic information contained in the PMDA package insert.

Excerpts from the package insert for crizotinib:

Confirmation of positive status for ALK fusion gene is necessary prior to therapy.

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the crizotinib package insert (in Japanese).

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

More information about drug labels on PharmGKB.

Genes and/or phenotypes found in this label

  • ALK
    • appears in:
      • Indications & usage section
    • source: Pharmaceuticals and Medical Devices Agency, Japan

Label History