The U.S. FDA has granted Fast Track designation to pelareorep, an investigational immunotherapy from Oncolytics Biotech, in combination with bevacizumab and FOLFIRI for second-line treatment of KRAS-mutant, microsatellite-stable (MSS) metastatic colorectal cancer.
The designation follows encouraging clinical data showing:
- 33% objective response rate
- Median progression-free survival of 16.6 months
- Median overall survival of 27 months
These results compare favorably to historical outcomes with standard-of-care therapy alone in a population traditionally resistant to immunotherapy.