Xalkori (crizotinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Pfizer Europe MA EEIG. Xalkori (crizotinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf. Revised September 2024. Accessed October 20, 2024.

Regulatory approvals

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

Indication	Statements
XALKORI as monotherapy is indicated for the first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).	1
XALKORI as monotherapy is indicated for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).	1
XALKORI as monotherapy is indicated for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC).	1
XALKORI as monotherapy is indicated for the treatment of paediatric patients (age >= 1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL).	1
XALKORI as monotherapy is indicated for the treatment of paediatric patients (age >= 1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK)-positive unresectable inflammatory myofibroblastic tumour (IMT).	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::ALK	Non-Small Cell Lung Cancer	Crizotinib
Sensitivity (+)	v::ALK	Non-Small Cell Lung Cancer	Crizotinib
Sensitivity (+)	v::ROS1	Non-Small Cell Lung Cancer	Crizotinib
Sensitivity (+)	v::ALK	Anaplastic Large Cell Lymphoma	Crizotinib
Sensitivity (+)	v::ALK	Inflammatory Myofibroblastic Tumor	Crizotinib