Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that v::ALK status confers therapeutic sensitivity to Crizotinib in patients with Inflammatory Myofibroblastic Tumor.

The European Medicines Agency (EMA) has authorized crizotinib for the treatment of pediatric patients (age >= 1 to < 18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK)-positive unresectable inflammatory myofibroblastic tumor (IMT).

This statement is based on a regulatory approval from the European Medicines Agency:

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).

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.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2024-08-22	European Medicines Agency	Indication received approval from the European Commission.