Accelerated approval based on a phase II single-arm trial doesn’t appear to be in the cards for Incyte Corp.’s retifanlimab as a second-line treatment for advanced or metastatic squamous cell anal cancer (SCAC). Following the lead of FDA reviewers June 24, the agency’s Oncologic Drugs Advisory Committee (ODAC) voted 13-4 to recommend that the agency defer its approval decision until more data are available from POD1UM-303, a confirmatory trial in platinum-naïve advanced SCAC.