The FDA granted fast‑track designation to pelareorep (Reolysin) in combination with bevacizumab and FOLFIRI for second‑line KRAS‑mutant, microsatellite‑stable metastatic colorectal cancer, citing response and survival signals from earlier studies. Oncolytics reported historical comparisons showing objective response rates around 33% with the combination versus ~10% with standard care. The designation targets an unmet population where checkpoint inhibitors show limited activity; company leadership highlighted pelareorep’s dual mechanism—direct oncolysis and immune activation—as a rationale for combination strategies. Oncolytics plans expedited development and continued interaction with the FDA to define registration‑enabling trials. If confirmatory randomized trials reproduce the signals, the therapy could change treatment options for KRAS‑mutant MSS mCRC, a historically difficult‑to‑treat subgroup.