Type C FDA Meeting Announced to Discuss Single-arm Registrational Pathway for Pelareorep in Anal Cancer
“We believe this upcoming FDA meeting is a critical step in advancing pelareorep toward a potential registration pathway in anal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Our goal is to align with the FDA on the statistical analysis plan and sample size for a potential pivotal single-arm study in second-line and later SCAC. In a setting with limited approved therapies, we believe the strength and durability of our data support this approach, and recent regulatory discussions in oncolytic virus development underscore the importance of demonstrating clear, durable clinical benefit with checkpoint inhibition. With few late-line options and no confounding checkpoint inhibitor data, SCAC offers a clearer efficacy signal and a potentially more efficient path to approval for pelareorep.”
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