FDA Grants Fast Track Designation to Oncolytics’s Pelareorep

Oncolytics Biotech has received U.S. Food and Drug Administration Fast Track designation for pelareorep in combination with a checkpoint inhibitor to treat patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) whose disease has progressed on or who are intolerant to one or more prior systemic therapies. The designation strengthens the company’s regulatory pathway toward a potential registrational study in a setting with no FDA-approved therapies after failure of current first-line treatment.

Fast Track Designation Supports Registrational Development

The FDA grants Fast Track designation to investigational therapies that address serious conditions with significant unmet medical needs. The program allows more frequent FDA interactions during development, rolling review of a future Biologics License Application (BLA), and potential Priority Review if eligibility criteria are met.

The designation follows an April 2026 meeting in which the FDA provided feedback on a potential registrational strategy for pelareorep in second-line and later SCAC. Based on that feedback, Oncolytics said it now has a defined regulatory framework to advance the program into a pivotal study.

The company noted that although checkpoint inhibitor plus chemotherapy is now the first-line standard of care for advanced SCAC, no FDA-approved treatment is available for patients whose disease progresses after this regimen, representing an estimated U.S. market opportunity approaching $1 billion annually.

Fast Track Backed by GOBLET Study Results

The designation is supported by previously reported results from the GOBLET study (NCT07280377) evaluating pelareorep with a checkpoint inhibitor in patients with advanced SCAC after prior therapy.

The study reported an objective response rate of approximately 30%, more than double historical response rates in this setting. Patients also achieved a median duration of response of approximately 15.5 months, while the 12-month overall survival rate reached 82%, comparing favorably with historical outcomes.

Third Fast Track Designation in Gastrointestinal Cancers

Chief Executive Officer Jared Kelly said the designation reflects continued regulatory progress for pelareorep and follows recent FDA alignment on its registrational development strategy in advanced anal cancer.

This is pelareorep’s third FDA Fast Track designation, following earlier designations in KRAS-mutated metastatic colorectal cancer in February 2026 and pancreatic cancer in 2022. According to the company, these regulatory milestones support its strategy of advancing pelareorep across gastrointestinal cancers with significant unmet medical needs.

Oncolytics plans to continue discussions with the FDA as it prepares a pivotal development program intended to support future regulatory submission for pelareorep in advanced SCAC.

Reference

Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer | Oncolytics Biotech Inc.