Oncolytics Biotech secured FDA Fast Track designation for pelareorep (Reolysin) combined with bevacizumab and FOLFIRI as second‑line therapy for KRAS‑mutant, microsatellite‑stable metastatic colorectal cancer. The designation follows encouraging response and survival signals from early studies showing objective responses and prolonged progression‑free survival versus historical controls. Pelareorep is an oncolytic reovirus intended to produce direct viral oncolysis and stimulate antitumor immunity; the company positions the agent as a platform to potentiate checkpoint blockade. Fast Track status is intended to expedite development and regulatory interactions in this underserved population.
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