FDA approves Zykadia for NSCLC-Novartis

The FDA has approved Zykadia (ceritinib, previously known as LDK378), from Novartis, for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic Non-Small Cell Lung Cancer (NSCLC) who have progressed on or are intolerant to crizotinib. The approval of Zykadia is based on a pivotal trial that included 163 patients with metastatic ALK+ NSCLC who progressed on or were intolerant to treatment with crizotinib.

The most common sites of metastases in the patient population studied were brain (60%), liver (42%) and bone (42%. Zykadia achieved an overall response rate of 54.6% and a median duration of response of 7.4 months [5.4-10.1 months]. The most common adverse reactions (incidence of at least 25%) were diarrhea, nausea, elevated transaminases, vomiting, abdominal pain, fatigue, decreased appetite and constipation). Two Phase III clinical trials comparing ceritinib with chemotherapy in treatment-naive and in previously-treated patients are ongoing and actively recruiting patients worldwide.