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# FDA, Oncolytics Agree on Reolysin SPA
- URL: https://www.fdaweb.com/fda-oncolytics-agree-on-reolysin-spa/
- Published: 2018-05-10T12:00:00.000Z
- Updated: 2026-09-15T00:04:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141405

FDA and Oncolytics Biotech have reached agreement on a special protocol assessment for the protocol design, clinical endpoints, and statistical analysis approach for the company’s Phase 3 study evaluating Reolysin (pelarorep) for treating metastatic breast cancer. FDA granted Reolysin fast-track designation 5/2017 for treating metastatic breast cancer.