FDA approves Novartis' ceritinib
FDA granted accelerated approval to Zykadia ceritinib ( LDK378) from Novartis AG (NYSE:NVS; SIX:NOVN) to treat anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) in patients who have progressed on or who are intolerant to Xalkori crizotinib from Pfizer Inc. (NYSE:PFE). The approval was based on data from the 163-patient Phase I ASCEND-1 trial showing Zykadia led to an overall response rate (ORR) of 54.6% and a median duration of response of 7.4 months in patients previously treated with Xalkori. Novartis said Zykadia will be available through specialty pharmacies in "a few weeks" at a wholesale acquisition cost (WAC) of $13,497 for a one-month supply.
Zykadia has breakthrough therapy designation from FDA for the indication and is the fourth drug with the designation to be approved by the agency. The small molecule ALK inhibitor is in Phase III testing for ALK-positive metastatic NSCLC. ...