Oncolytics gets FDA Fast Track for pelareorep in 2L KRAS-mutant MSS mCRC; interim data expected YE 2026

ONCOLYTICS BIOTECH INC

FDA Fast Track Designation for pelareorep + bevacizumab + FOLFIRI in second-line KRAS-mutant MSS metastatic colorectal cancer.
Clinical data showed 33% ORR (vs ~10% SOC), 16.6-month PFS (vs 5.7 mo SOC), 27-month OS (vs 11.2 mo SOC).
Company plans controlled study with first site activated March 2026; interim data expected by end of 2026.
Estimated addressable market $3-5 billion annually for this difficult-to-treat population.

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