Pelareorep and mFOLFIRINOX with and without atezolizumab - (GOBLET)

July 20, 2026: Oncolytics Biotech Inc. (NASDAQ: ONCY) announced the FDA granted Fast Track designation to pelareorep in combination with a checkpoint inhibitor for patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) who progressed on or were intolerant to one or more prior systemic therapies. The company said the designation follows positive feedback from an April 2026 FDA meeting on a potential registrational development strategy and provides a clearer regulatory framework to advance toward a pivotal study.

The Fast Track decision is supported by results from the GOBLET study of pelareorep plus a checkpoint inhibitor in advanced SCAC after prior therapy, which the release cites as showing an objective response rate of ~30%, median duration of response ~15.5 months, and 12-month overall survival of 82%.

Oncolytics noted there are no FDA-approved therapies for patients whose disease progresses after current first-line checkpoint inhibitor plus chemotherapy in SCAC. This is pelareorep’s third FDA Fast Track designation in gastrointestinal cancers, following KRAS-mutated metastatic colorectal cancer (February 2026) and pancreatic cancer (late 2022).