FDA Fast Track designation for pelareorep in anal cancer
Oncolytics Biotech disclosed FDA Fast Track designation for pelareorep with a checkpoint inhibitor in second-line or later anal cancer.
The designation targets inoperable locally recurrent or metastatic squamous cell anal canal cancer following progression or intolerance to prior systemic therapy.
The company cited GOBLET data showing about a 30% objective response rate, median duration of response of about 15.5 months, and 12-month overall survival of 82%.
The program targets an estimated U.S. commercial opportunity approaching $1 billion annually, with no FDA-approved therapies post first-line standard of care.
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