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Raludotatug Deruxtecan Receives FDA Breakthrough Therapy Status for Platinum-Resistant Ovarian Cancer
_↗ merck.com
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Daiichi Sankyo and Merckhave announced that their investigational drug, raludotatug deruxtecan (R-DXd), has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA). This designation is for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancers that express CDH6 and have been previously treated with bevacizumab. This marks a significant milestone, as it is the first BTD for raludotatug deruxtecan and the second since Daiichi Sankyo and Merck began their collaboration. This is also the fifteenth BTD granted by the FDA for a drug in Daiichi Sankyo's oncology portfolio. have announced that their investigational drug, raludotatug deruxtecan (R-DXd), has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA). This designation is for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancers that express CDH6 and have been previously treated with bevacizumab. This marks a significant milestone, as it is the first BTD for raludotatug deruxtecan and the second since Daiichi Sankyo and Merck began their collaboration. This is also the fifteenth BTD granted by the FDA for a drug in Daiichi Sankyo's oncology portfolio.

The FDA's BTD is designed to accelerate the development and review of new medicines for serious conditions where there is a substantial unmet medical need and where preliminary clinical results show a notable improvement over existing treatments. The BTD for raludotatug deruxtecan was based on promising data from a phase 1 trial and the ongoing REJOICE-Ovarian01 phase 2/3 trial. The drug is a specifically engineered, first-in-class CDH6-directed antibody drug conjugate (ADC) that was discovered by Daiichi Sankyo and is being jointly developed with Merck. The decision is seen as an important step in providing a novel treatment option for patients with limited choices once their ovarian cancer becomes resistant to standard platinum-based chemotherapy. With no current CDH6-directed medicine approved for any cancer, this new therapy has the potential to become a crucial treatment for patients whose tumors express the CDH6 protein, which is found in an estimated 65% of ovarian cancer cases. The companies are committed to continuing their research and working closely with the FDA to bring this potential new option to the scientific and patient communities.

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