ARTICLE | Clinical News

Rociletinib regulatory update

October 5, 2015 7:00 AM UTC

FDA and EMA accepted regulatory applications for rociletinib to treat non-small cell lung cancer (NSCLC) in patients who have the EGFR T790M mutation and have been previously treated with an EGFR-targeted therapy. FDA granted Priority Review to the NDA, which has a PDUFA date of March 30, 2016. EMA granted accelerated assessment to rociletinib. ...