Oncolytics Biotech announced a Type C FDA meeting on April 16, 2026, to discuss a potential single-arm pivotal study for pelareorep in second-line squamous cell anal carcinoma.
Key takeaways
Type C meeting with FDA scheduled for April 16, 2026, to align on a registrational development path.
Proposed pivotal study design targets approximately 60 to 70 patients with ORR as the primary endpoint.
Study focuses on second-line and later SCAC patients who have exhausted approved therapies.
GOBLET study Cohort 4 demonstrated approximately 30% ORR with a 17-month median duration of response.