Oncolytics Aligns with FDA on Pivotal Study Design for Colorectal Cancer Drug

Oncolytics Biotech announced it received written feedback from the U.S. Food and Drug Administration (FDA) aligning on a registrational path for its drug, pelareorep, in second-line RAS-mutant, microsatellite stable (MSS) metastatic colorectal cancer. The feedback supports transitioning the ongoing REO 033 study into a pivotal Part B expansion.

Key Details

• Approval Pathway: The FDA's feedback provides alignment on a potential accelerated approval pathway based on objective response rate (ORR), with progression-free survival (PFS) serving as the basis for full approval.
• Study Design: The pivotal Part B expansion is planned to follow the generation of supportive clinical data from the ongoing randomized Part A of the REO 033 study.
• Next Steps: Based on the feedback, Oncolytics will pursue an End-of-Phase meeting with the FDA to finalize the registration program and plans to initiate Part B start-up activities once positive interim data from Part A is available.