Oncolytics Biotech to meet FDA on registrational pathway for REO 033 colorectal cancer trial
ONCY•FDA meeting planned for REO 033
Oncolytics Biotech will hold an FDA Type D meeting in the first half of August 2026 to discuss a registrational pathway for REO 033.
The plan adds a registration-directed Part B to REO 033, a randomized study in second-line RAS-mutant MSS metastatic colorectal cancer.
Part B is designed to support potential accelerated approval and traditional full approval within the same study, using blinded independent central review.
Expected timing for data and enrollment
Initial tumor response data from Part A is expected by year-end 2026; Part B enrollment is targeted for the first quarter of 2027, subject to FDA feedback.
