Raludotatug deruxtecan granted Breakthrough Therapy Designation by U.S. FDA for patients with CDH6 expressing platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers previously treated with bevacizumab

CAR-T Digest - August 2020

Weekly Digest - September 2025

15 September 2025: Raludotatug deruxtecan granted Breakthrough Therapy Designation by U.S. FDA for patients with CDH6 expressing platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers previously treated with bevacizumab

Raludotatug deruxtecan (R-DXd), a CDH6-directed DXd antibody–drug conjugate from Daiichi Sankyo and Merck, received its first Breakthrough Therapy Designation (BTD) from the U.S. FDA for adults with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who were previously treated with bevacizumab
The designation is based on data from a Phase 1 trial and the ongoing Phase 2/3 REJOICE-Ovarian01 trial, with subgroup analyses presented at major oncology meetings between 2023 and 2025
This marks the second BTD since the start of the Daiichi Sankyo–Merck collaboration and the fifteenth BTD across Daiichi Sankyo’s oncology portfolio
The FDA’s BTD is intended to speed development and review of medicines showing substantial improvement on clinically significant endpoints over current treatments for serious conditions
Both companies emphasized the urgent need for new options in platinum-resistant ovarian cancer and highlighted plans to share more REJOICE-Ovarian01 data at upcoming scientific meetings