The U.S. Food and Drug Administration granted fast‑track designation to pelareorep (Reolysin) in combination with bevacizumab and FOLFIRI for second‑line treatment of KRAS‑mutant, microsatellite‑stable metastatic colorectal cancer. Sponsor Oncolytics Biotech cited compelling response and progression‑free survival signals from earlier trials to justify expedited development. Oncolytics said the designation validates pelareorep’s potential as a platform oncolytic immunotherapy that may prime tumors for checkpoint blockade. Fast‑track status enables closer FDA interaction and potential rolling submissions; the company highlighted ORR and PFS improvements versus historical controls as the clinical basis for the regulatory decision.