Zykadia ceritinib regulatory update

FDA granted accelerated approval to Novartis' Zykadia ceritinib 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. 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 of $13,497 for a 1-month supply. ...