The FDA granted breakthrough remedy designation to R-DXd for adults with CDH6-expressing platinum-resistant ovarian, peritoneal or fallopian tube cancers.
Raludotatug deruxtecan (R-DXd) has been granted breakthrough remedy designation by the U.S. Meals and Drug Administration (FDA) for the remedy of grownup sufferers with platinum-resistant epithelial ovarian, main peritoneal or fallopian tube cancers expressing CDH6 who’ve obtained prior remedy with Avastin (bevacizumab).
“Sufferers have restricted remedy choices as soon as ovarian most cancers turns into immune to platinum-based chemotherapy, highlighting the pressing want for brand spanking new medicines that may enhance affected person outcomes,” Dr. Ken Takeshita, world head, R&D, Daiichi Sankyo, stated in a information launch. “The receipt of breakthrough remedy designation represents an vital step ahead in our efforts to advance raludotatug deruxtecan as a novel medication for sufferers with CDH6 expressing platinum-resistant ovarian, main peritoneal or fallopian tube cancers beforehand handled with [Avastin].”
R-DXd is a possible first-in-class antibody drug conjugate designed to focus on CDH6. It’s a part of the DXd antibody drug conjugate platform, particularly engineered by Daiichi Sankyo. The remedy was found by Daiichi Sankyo and is being collectively developed with Merck, which is called MSD outdoors of the US and Canada.
The FDA breakthrough remedy designation is meant to hurry the event and regulatory overview of potential new medicines for severe situations with unmet medical wants. To qualify, a drugs should present promising early scientific outcomes indicating a considerable enchancment on a significant scientific endpoint in contrast with current therapies.
The FDA’s choice to grant breakthrough remedy designation was supported by findings from a section 1 trial and the continuing REJOICE-Ovarian01 section 2/3 trial. Outcomes from a subgroup evaluation of the section 1 trial had been first shared on the 2023 European Society for Medical Oncology assembly, with additional subgroup information later introduced on the 2024 Society for Gynecologic Oncology Annual Assembly on Ladies’s Most cancers and the 2025 European Society for Medical Oncology Gynaecological Cancers Congress. This marks the primary breakthrough remedy designation for R-DXd and the second designation achieved beneath the collaboration between Daiichi Sankyo and Merck.
Within the section 1 trial, a subgroup of fifty sufferers with measurable ovarian most cancers handled with R-DXd (4.8 to eight milligrams per kilogram) achieved a confirmed goal response fee of 46% by investigator evaluation. Amongst these, one full response, 22 partial responses and 4 unconfirmed responses had been reported, leading to a illness management fee of 98%. Median length of response was 11.2 months and median progression-free survival was 7.9 months, primarily based on information as of July 14, 2023. Responses had been noticed throughout sufferers with completely different ranges of tumor CDH6 expression.
Trial Design
The 2-part, multicenter, open-label, first-in-human section 1 trial is evaluating the security and efficacy of R-DXd in adults with superior ovarian most cancers who had been beforehand handled with platinum-based chemotherapy and a taxane. The trial initially included sufferers with renal cell carcinoma resistant or refractory to straightforward remedy, however that portion was discontinued.
Within the dose-escalation a part of the research, the first goal was to evaluate security and tolerability of accelerating doses to find out the utmost tolerated dose and beneficial dose for growth. The dose-expansion half is designed to additional consider security and efficacy in sufferers with superior ovarian most cancers and superior renal cell carcinoma.
The research is assessing security endpoints corresponding to dose-limiting toxicities and negative effects, in addition to efficacy endpoints together with goal response fee, length of response, illness management fee, scientific profit fee, time to response and progression-free survival. Pharmacokinetic and exploratory biomarker endpoints are additionally being studied.
The section 1 trial enrolled 179 sufferers in Asia and North America. Extra particulars can be found on ClinicalTrials.gov.
References
- “Raludotatug Deruxtecan Granted Breakthrough Remedy Designation by U.S. FDA for Sufferers with CDH6 Expressing Platinum-Resistant Ovarian, Main Peritoneal or Fallopian Tube Cancers Beforehand Handled with Bevacizumab.” DaiichiSankyo. Information Launch. September 15, 2025.
- “Raludotatug Deruxtecan Continues to Display Promising Scientific Exercise in Sufferers with Superior Ovarian Most cancers in Early Trial.” DaiichiSankyo. Information Launch. October 22, 2023.
For extra information on most cancers updates, analysis and training, don’t neglect to subscribe to CURE®’s newsletters right here.
