Oncolytics Biotech receives FDA Fast Track for pelareorep in second-line anal cancer

ONCOLYTICS BIOTECH INC

FDA granted Fast Track for pelareorep + checkpoint inhibitor in inoperable/metastatic squamous cell anal carcinoma after prior therapy.
GOBLET study showed ORR ~30% (vs historical ~15%), median DOR ~15.5 months, 12-month OS 82% (vs 45.7%).
No FDA-approved therapies exist for patients progressing after first-line standard of care; estimated US market ~$1B annually.
Third Fast Track designation in GI cancers (after KRAS-mCRC Feb 2026 and pancreatic cancer 2022).
Company believes clear regulatory framework in place for pivotal study following April 2026 FDA meeting.

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