Oncolytics Biotech Receives FDA Fast Track Designation for Pelareorep in Colorectal Cancer

Wednesday, Feb 4, 2026 12:10 pm ET1min read
ONCY--

Oncolytics Biotech has received FDA Fast Track Designation for pelareorep in second-line KRAS-mutant MSS metastatic colorectal cancer. The treatment showed 33% overall response rate, 16.6-month progression-free survival, and 27-month overall survival, significantly improving on standard of care for a difficult-to-treat population. Pelareorep now has Fast Track Designation for two gastrointestinal cancers, solidifying its potential as an immunotherapeutic platform therapy in gastrointestinal cancers.

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