Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that v::ALK status confers therapeutic sensitivity to Crizotinib in patients with Anaplastic Large Cell Lymphoma.

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 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 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.