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.
The agency said that its efficacy analysis would focus solely on confirmed responses. The company’s New Drug Application contained immature data sets based on both unconfirmed response rates and confirmed response rates, according to Clovis.
The updated results contain a lower-than-expected rate of confirmed responses to the drug.
Rociletinib is a novel, oral, targeted covalent mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M. Data from both the single-arm TIGER-X and TIGER-2 clinical trials served as the basis for the U.S. and E.U. regulatory submissions for the treatment of advanced mutant EGFR T790M-positive lung cancer.