Oncolytics Biotech wins FDA Fast Track status for pelareorep in second-line anal cancer
ONCY•FDA Fast Track designation for pelareorep
Oncolytics Biotech won FDA Fast Track designation for pelareorep with a checkpoint inhibitor in second-line or later anal cancer.
- Designation covers inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal following prior systemic therapy.
- GOBLET study data cited an objective response rate near 30% with a median duration of response about 15.5 months.
- Oncolytics pegged the U.S. opportunity at about USD 1 billion a year, citing no FDA-approved options post first-line standard of care.
