Daiichi Sankyo and Merck Receives FDA Breakthrough Therapy Designation for Raludotatug Deruxtecan in Ovarian and Related Cancers
Tuesday, September 16, 2025
Daiichi Sankyo and Merck announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to their investigational antibody-drug conjugate, raludotatug deruxtecan (R-DXd), for the treatment of adult patients with CDH6-expressing platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers who have previously received bevacizumab.
Ovarian cancer remains a significant global health challenge, with more than 324,000 new cases diagnosed in 2022. Around 70–80% of patients with advanced disease relapse after platinum-based chemotherapy, and prognosis is particularly poor in cases of platinum resistance.
CDH6, a cadherin family protein, is overexpressed in many ovarian cancers, especially high-grade serous carcinoma, and is found in about 65% of cases. There are currently no approved medicines targeting CDH6.
Raludotatug deruxtecan is a potential first-in-class antibody-drug conjugate (ADC) targeting CDH6. It was discovered by Daiichi Sankyo and is being jointly developed with Merck. The FDA’s BTD programme is designed to speed up the development and review of medicines showing promising clinical results and addressing serious conditions with limited treatment options.
The designation was supported by findings from a phase 1 trial and ongoing results from the global REJOICE-Ovarian01 phase 2/3 study. Subgroup analyses of the phase 1 study have been presented at major scientific meetings, including the European Society for Medical Oncology and the Society for Gynaecologic Oncology.
This is the first BTD granted for raludotatug deruxtecan and the second for the Daiichi Sankyo and Merck partnership.
Source: merck.com
