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Oncolytics Biotech Inc. received written feedback from the U.S. Food and Drug Administration regarding the design of a…
ONCYOncolytics Biotech Inc
Oncolytics Biotech Inc. received written feedback from the U.S. Food and Drug Administration regarding the design of a potential pivotal Part B expansion of its ongoing REO 033 study for second-line RAS-mutant, microsatellite stable metastatic colorectal cancer. The FDA aligned with the company's proposal to use objective response rate for accelerated approval and progression-free survival for full approval. Oncolytics elected to forego a scheduled Type D meeting in favor of an End-of-Phase meeting to finalize registration program elements. This regulatory alignment supports the potential transition from Part A to a pivotal Part B study upon availability of interim clinical data, potentially accelerating the path to market for pelareorep. Oncolytics Biotech Inc. is a clinical-stage biotechnology company developing pelareorep, an investigational immunotherapy for cancer treatment.