Oncolytics Biotech announced that its investigational immunotherapy, pelareorep, in combination with a checkpoint inhibitor, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designation is for the treatment of patients with inoperable, recurrent, or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed after prior systemic therapy.
Key Details
- Indication: The Fast Track designation applies to pelareorep for second-line and later treatment of advanced or metastatic anal cancer, a condition with no currently FDA-approved therapies for patients who progress after first-line standard of care.
- Regulatory Impact: This designation facilitates more frequent interactions with the FDA to expedite the drug's development and review. It follows positive feedback received from the FDA in April 2026 regarding a potential registrational development strategy.
- Supporting Data: The designation is supported by data from the GOBLET study, which showed an objective response rate of approximately 30% (more than double historical rates) and a 12-month overall survival rate of 82% (compared to 45.7% historically).