Annotation of U.S. Food and Drug Administration (FDA) label information
for crizotinib
and ALK, ROS1
Summary
The FDA-approved drug label for crizotinib (XALKORI) states that it is indicated for treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK-positive as detected by an FDA-approved test, and for patients with metastatic NSCLC whose tumors are ROS1-positive.
Annotation
Excerpts from the crizotinib (XALKORI) label:
XALKORI is a kinase inhibitor indicated for the treatment of patients with: metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test...metastatic NSCLC whose tumors are ROS1-positive.
Select patients for the treatment of metastatic NSCLC with XALKORI based on the presence of ALK or ROS1 positivity in tumor specimens...Information on FDA-approved tests for the detection of ALK rearrangements in NSCLC is available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm.
An FDA-approved test for the detection of ROS1 rearrangements in NSCLC is not currently available. Refer to Section 14.2 for information on the tests used in the clinical study to identify patients with ROS1 rearrangements in NSCLC.
The ROS1 status of NSCLC tissue samples was determined by laboratory-developed break-apart FISH (96%) or RT-PCR (4%) clinical trial assays. For assessment by FISH, ROS1 positivity required that >=15% of a minimum of 50 evaluated nuclei contained a ROS1 gene rearrangement.
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the crizotinib drug label.
*Disclaimer: The contents of this page have not been endorsed by the FDA and are the sole responsibility of PharmGKB.