Oncolytics secures FDA alignment on pivotal anal cancer study for pelareorep

ONCOLYTICS BIOTECH INC

FDA agreed on a randomized controlled pivotal trial design for pelareorep in post-first-line metastatic SCAC, targeting accelerated and full approval.
Prior pelareorep+checkpoint data showed median duration of response 15.5 months vs 9.5 months SOC; 12-month survival 82% vs 45.7%.
No FDA-approved therapies exist for SCAC after first-line chemo/checkpoint; over 10,000 US patients affected annually.
Company will finalize protocol using FDA feedback; study enables multiple endpoint assessments for potential simultaneous approvals.

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