Clovis Oncology Receives Notification of PDUFA Extension for Rociletinib

Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for Clovis' New Drug Application (NDA) for rociletinib by the standard extension period of three months with the new goal date of June 28, 2016. Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation. Clovis submitted a Major Amendment on November 16, 2015 in response to the FDA's request for additional clinical data for both the 500mg and 625mg BID dose patient groups for rociletinib. As expected, the FDA extended the PDUFA goal date to allow additional time for review of the new information requested by the Agency.