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Oncolytics Biotech® Aligns with FDA on Registrational Path for Second-Line RAS-Mutant ...
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Fusion42 · 21 August 2026 · Fusion42 review
Oncolytics Biotech has aligned with the FDA on a registrational pathway for expanding its REO 033 study into a pivotal trial for second-line RAS-mutant, microsatellite stable metastatic colorectal cancer, with potential accelerated approval based on objective response rate and progression-free survival supporting full approval.
This Wire brief sits within Fusion42's coverage of Biotech.
◆ ◆ The Wire takeaway
Your oncology drug development just gained a faster clinical path through FDA alignment on a pivotal study design with an accelerated approval route. Prepare to initiate Part B trial activities quickly once interim Part A data is positive to capture this window.
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1 source · 18 Aug 2026
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