Xalkori (crizotinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Pfizer, Inc. Xalkori (crizotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s021lbl.pdf. Revised July 2017. Accessed October 6, 2026.

View API

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
XALKORI is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. 2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (1) v::ALK Non-Small Cell Lung Cancer Crizotinib
FDA (1) v::ROS1 Non-Small Cell Lung Cancer Crizotinib