Oncolytics says FDA aligns on pivotal expansion path for REO 033 colorectal cancer trial
ONCY•Planned next steps for Part B
The proposed pathway could support accelerated approval based on tumor response, with progression-free survival intended to support full approval.
Management plans to start Part B preparation once Part A interim data are positive, aiming to shorten the timeline into a pivotal stage.
Pelareorep combination therapy already holds FDA Fast Track designation in second-line RAS-mutant, MSS metastatic colorectal cancer.
FDA feedback supports a registrational path
Oncolytics says it received FDA written feedback supporting a registrational path to expand its REO 033 colorectal cancer study into a pivotal Part B.
Trial results have not been presented; a Part B decision will follow interim clinical data from the ongoing randomized Part A.
