Oncolytics Biotech Inc. (NASDAQ: ONCY) announced that the U.S. Food and Drug Administration has granted Fast Track designation to pelareorep in combination with a checkpoint inhibitor for the treatment of patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal who have progressed on or were intolerant to one or more prior lines of systemic therapy.

The designation is the third granted to pelareorep in gastrointestinal cancers, following similar designations for KRAS-mutated metastatic colorectal cancer in February 2026 and pancreatic cancer in late 2022.

Fast Track designation allows for more frequent interactions with the FDA during development, rolling review of a future Biologics License Application, and eligibility for Priority Review, if applicable.

The company states the designation is supported by data from its GOBLET study, which reported an objective response rate of approximately 30% in patients with advanced squamous cell anal carcinoma, compared to historical rates of around 15%. The study also reported a median duration of response of approximately 15.5 months versus 9.5 months historically, and a 12-month overall survival rate of 82% compared to a historical 45.7%.

According to the press release, there are currently no FDA-approved therapies for patients whose disease progresses following first-line checkpoint inhibitor plus chemotherapy treatment, representing what the company estimates to be a U.S. commercial opportunity of approximately $1 billion annually.

Oncolytics also noted that an April 2026 meeting with the FDA provided feedback regarding a potential registrational development strategy for pelareorep in this indication.

"This Fast Track designation represents another important regulatory milestone for Oncolytics," said Jared Kelly, Chief Executive Officer. "Our April meeting with the FDA provided important clarity regarding a potential registrational pathway for pelareorep in second-line and later anal cancer, reinforcing our confidence in the program."

Pelareorep is an investigational intravenously delivered immunotherapy that the company is developing across multiple gastrointestinal cancer indications.