FDA panel: Delay decision on Clovis' rociletinib

FDA's Oncologic Drugs Advisory Committee voted 12-1 on Tuesday that FDA should await the outcome of the confirmatory Phase III TIGER-3 trial of rociletinib ( CO-1686) from Clovis Oncology Inc. (NASDAQ:CLVS) before the agency decides whether to approve the lung cancer therapy. Clovis is seeking accelerated approval of rociletinib. Its PDUFA date is June 28.

Clovis expects to complete enrollment of TIGER-3 in late 2018, and could report data in late 2018 or 1H19. The study's primary endpoint is progression-free survival (PFS). ...