Oncolytics received FDA Fast Track designation for pelareorep with a checkpoint inhibitor in second-line and later squamous cell carcinoma of the anal canal.
Key Highlights:
- FDA granted Fast Track for pelareorep + checkpoint inhibitor for inoperable, locally recurrent or metastatic SCAC after prior systemic therapy, enabling expedited development.
- Designation allows more FDA interactions, rolling BLA review and potential Priority Review, supporting a registrational pathway for the program.
- Supported by GOBLET study data showing ~30% objective response rate, ~15.5-month median duration of response, and 12‑month OS of 82%.
- This is pelareorep’s third GI Fast Track (colorectal, pancreatic, now anal), reinforcing regulatory momentum toward pivotal studies.
Original SEC Filing:
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