Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized crizotinib for the treatment of pediatric patients (age >= 1 to < 18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL).

This is written in the approval document as:

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).

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::ALK	Anaplastic Large Cell Lymphoma	Crizotinib