RE:RE:RE:RE:RE:ONCY January 2024 slide deck - over 120 panc pts studiedFDA said that it “may be acceptable” in a confirmatory trial for sponsors to evaluate the drug in the same cancer type but in another line of therapy, such as earlier-stage disease, as ONCY intends to do in L1 pancreatic cancer and potentially in mBC. “This approach has the potential to provide access to effective drugs to patients with earlier-stage disease in which benefit may be greater, and it facilitates patient accrual when a drug has already received accelerated approval for a later-stage indication,” the agency wrote.