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Oncolytics Biotech® Aligns with FDA on Registrational Path for Second-Line RAS-Mutant ...

Published

18 August 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at biospace.com →

◆ Verified

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.

◆ Coverage

1 source · 18 Aug 2026

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◆ Topics

Biotechfda-approvalclinical-trialscolorectal-canceraccelerated-approvalimmunotherapy