Therapeutic Response

v::ALK status confers therapeutic sensitivity to Ceritinib in patients with Non-Small Cell Lung Cancer.

Statements

Source and description
Zykadia (ceritinib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to ceritinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Zykadia (ceritinib) [product information]. EMA. The European Medicines Agency (EMA) has authorized ceritinib for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Zykadia (ceritinib) [product information]. EMA. The European Medicines Agency (EMA) has authorized ceritinib for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Ceritinib Monotherapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved ceritinib for reimbursement as a treatment option for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib, and whose ALK rearrangement has been demonstrated by an accurate and validated test method.