Raludotatug deruxtecan (R-DXd), a novel CDH6-targeted antibody-drug conjugate developed by Daiichi Sankyo and Merck, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA). The designation applies to adult patients with platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancers expressing CDH6 who have previously been treated with bevacizumab.
BTD is granted to drugs showing promising early clinical data for serious conditions with unmet medical needs, enabling accelerated development and review. The FDA’s decision was based on data from a Phase 1 trial and ongoing Phase 2/3 REJOICE-Ovarian01 trial, with results presented at major oncology conferences including the European Society for Medical Oncology and the Society for Gynecologic Oncology.
“Patients with platinum-resistant ovarian cancer face limited options, so this designation marks a key milestone toward advancing raludotatug deruxtecan as a new treatment for CDH6-expressing tumors,” said Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo.
Eliav Barr, MD, Senior Vice President and Chief Medical Officer at Merck Research Laboratories, emphasized the potential of the therapy to improve outcomes in this challenging patient population and highlighted plans to share further data from the REJOICE trial at upcoming scientific meetings.
Raludotatug deruxtecan represents a promising new targeted therapy option for patients with aggressive, difficult-to-treat gynecologic cancers, underscoring ongoing efforts to address significant unmet needs in oncology.