Posted by Michael Wonder on 23 Feb 2017
Novartis drug Zykadia receives FDA priority review for first-line use in patients with ALK+ metastatic NSCLC
23 February 2017 - Priority review based on Phase III study results showing 16.6 month median progression-free survival in previously untreated ALK+ metastatic NSCLC patients on Zykadia vs. 8.1 months treated with chemotherapy.
Novartis today announced that the US FDA accepted the Company's supplemental New Drug Application (sNDA) for filing, and granted Priority Review for the expanded use of Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small- cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The FDA also granted breakthrough therapy designation to Zykadia for the first-line treatment of patients with ALK+ metastatic NSCLC with metastases to the brain.
