Posted by Michael Wonder on 22 Jan 2023
DualityBio announces DB-1303 granted fast track designation by the US FDA for the treatment of advanced, recurrent or metastatic endometrial carcinoma with HER2 overexpression
20 January 2023 - Duality Biologics announced that the US FDA has granted fast track designation to DB-1303 for the treatment of patients with advanced, recurrent or metastatic endometrial carcinoma with HER2 overexpression who have progressed on or after standard systemic treatment.
DB-1303 is a novel antibody drug conjugate comprised of anti-HER2 monoclonal antibody, enzymatically cleavable peptide-linker, and a proprietary topoisomerase I inhibitor P1003.
