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FDA aligns with Oncolytics Biotech on design for pivotal Part B expansion of REO 033 study
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.