Nouscom, a clinical-stage biotech company developing next-generation immunotherapies to treat cancer at all stages, from early cancer interception to late-stage metastatic disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to NOUS-209 for the prevention of Lynch Syndrome (LS)-associated cancers in LS carriers with genetically confirmed mismatch repair (MMR) mutations.
Fast Track Designation is granted to investigational therapies that have the potential to address serious conditions with significant unmet medical need. It is designed to expedite development and review through more frequent, direct interactions with the FDA, and confers eligibility for Accelerated Approval, Rolling Review of a Biologics License Application (BLA), and Priority Review at BLA submission.