Oncolytics Biotech said the FDA 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. The agency’s action reflects promising response and survival signals from early clinical cohorts where the viral oncolytic therapy showed higher objective responses versus historical expectations. Pelareorep combines selective viral oncolysis with stimulation of antitumor immunity, potentially enhancing responses to checkpoint inhibitors in immune‑excluded tumors. For readers: Fast Track designation is a regulatory mechanism intended to expedite review of drugs addressing unmet medical needs for serious conditions. The designation may facilitate more frequent FDA interactions and rolling submissions for pivotal data, but sponsors must still generate confirmatory evidence. Oncolytics will likely accelerate combination trials and biomarker programs to define populations that derive the largest benefit.