Pelareorep receives FDA Fast Track for 2L KRAS‑mutant MSS metastatic colorectal cancer.

The FDA granted Fast Track Designation to pelareorep, given with bevacizumab and FOLFIRI, for second‑line treatment of KRAS‑mutant, microsatellite‑stable metastatic colorectal cancer, and Oncolytics said it applied after focusing on gastrointestinal cancer and reviewing its colorectal data.

Oncolytics Biotech announced that the U.S. Food and Drug Administration has granted Fast Track Designation to pelareorep in combination with bevacizumab and FOLFIRI for patients with KRAS‑mutant, microsatellite‑stable metastatic colorectal cancer in the second‑line setting. The company said the application followed an increased focus on gastrointestinal cancers and analysis of existing colorectal data. Key details: - The FDA granted Fast Track Designation to pelareorep with bevacizumab and FOLFIRI for 2L KRAS‑mutant, MSS metastatic colorectal cancer. - Oncolytics Biotech is the clinical‑stage immunotherapy company developing pelareorep. - The company applied for the designation after focusing on gastrointestinal cancer and reviewing its colorectal data. - The company notes pelareorep now has Fast Track Designation for two gastrointestinal cancers. Summary: The Fast Track designation is a regulatory recognition for pelareorep in this patient group. Undetermined at this time.