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.
Furthermore, an Accelerated Approval in the early stage of disease in pancreatic would result in pelareorep to be commercialized and marketed, thus producing a revenue stream and sufficient cash for ONCY to run follow-on Accelerated Approvals and confirmatory Phase 3 clinical trials, wthat would thus create even greater cash flows from the expansion of approved immuno-therapeutic indications using pelareorep.