Posted by Michael Wonder on 15 Sep 2025
Raludotatug deruxtecan granted breakthrough therapy designation by US FDA for patients with CDH6 expressing platinum-resistant ovarian, primary peritoneal or fallopian tube cancers previously treated with bevacizumab
15 September 2025 - Raludotatug deruxtecan has been granted breakthrough therapy designation by the US FDA for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with bevacizumab.
The FDA granted this breakthrough therapy designation based on data from a Phase 1 trial and the on-going REJOICE-Ovarian01 Phase 2/3 trial.
