BioCentury
ARTICLE | Company News

FDA panel to review Clovis' rociletinib

February 13, 2016 2:58 AM UTC

FDA's Oncologic Drugs Advisory Committee will meet on April 12 to discuss an NDA from Clovis Oncology Inc. (NASDAQ:CLVS) for rociletinib ( CO-1686) 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. Its PDUFA date is June 28.

Clovis amended rociletinib's NDA in November at FDA's request after the company said the rate of confirmed responses to rociletinib was lower than previously reported unconfirmed response rates that served as the original NDA's primary basis. In December, FDA extended the PDUFA date by three months (see BioCentury Extra, Nov. 16, 2015). ...