Oncolytics says in alignment with FDA following pelareorep Type C meeting

Oncolytics (ONCY) announced that a Type C meeting with the FDA has resulted in alignment on the design of a pivotal clinical study to support approval of pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal. “We want to thank the FDA for its very clear guidance and helping us create an efficient pathway for pelareorep in a disease that is desperate for new treatments,” said Jared Kelly, Chief Executive Officer of Oncolytics. “While a single-arm study was possible in this setting, following a productive discussion with the FDA and in consideration of recent regulatory decisions regarding similar studies, we have aligned on a randomized controlled trial designed to potentially support both accelerated approval and full approval within the same study. This approach directly addresses relevant and rigorous evidentiary standards while allowing for approval based on multiple endpoint assessments.” The company plans to incorporate FDA feedback into the final protocol, which is expected to be a single, randomized controlled trial for which accelerated approval and full approval could be applied at different points in time.