FDA has requested additional clinical data from Clovis Oncology Inc., for the agency’s efficacy analysis of the 500mg and 625mg BID dose patient groups for rociletinib. Clovis said it would provide the information in a major amendment to the FDA.
Over the course of his first six months as NCI director, Anthony Letai has contended with federal budget turbulence, a record-setting government shutdown, and concerns about the flow of over research dollars.
