Zykadia (ceritinib) is EU approved for anaplastic lymphoma kinase (ALK)-positive advanced NSCLC- Novartis

Novartis has announced that the European Commission has approved Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. The approval of Zykadia in the European Union (EU) provides patients with advanced ALK+ NSCLC previously treated with crizotinib (Xalkori) a new treatment option that specifically targets the genetic makeup of their cancer.

The EU approval of Zykadia is based on data from two global, multicenter, open-label, single-arm studies [Study A (also known as ASCEND-1) and Study B (also known as ASCEND-2)]. Data from Study A demonstrated patients with ALK+ NSCLC who received Zykadia 750 mg daily after previous treatment with chemotherapy followed by an ALK inhibitor experienced an overall response rate (ORR) of 56.4%. Detailed results from Study B will be presented at an upcoming medical congress.

Zykadia is approved for patients with ALK+ NSCLC in the United States and other countries within North America, South America, Central America and Asia. Additional regulatory reviews for Zykadia are underway worldwide.

Comment: There are limited treatment options for patients with ALK+ NSCLC, who tend to be non-smokers and younger than patients without an ALK translocation.

Comment: Ceritinib is structurally distinct from crizotinib (Xalkori), and has a 20-fold greater potency against the target than its more advanced rival, making it a prime candidate for use in resistant patients. Despite high initial responses to Xalkori therapy, patients usually acquire resistance to the drug and relapse within a year. Resistance mechanisms involved include ALK gene mutation, ALK gene amplification or activation of other tyrosine kinases such as EFGR. Approximately 2-7% of patients with NSCLC harbour the ALK gene rearrangement, which causes cancer growth.