Raludotatug deruxtecan receives breakthrough machine designation
September 16, 2025
1 min learn
Raludotatug deruxtecan has acquired breakthrough remedy designation for therapy of sure adults with platinum-resistant epithelial ovarian most cancers, main peritoneal or fallopian tube cancers that specific CDH6.
This indication applies to adults beforehand handled with bevacizumab (Avastin, Genentech), in line with a press launch.
Raludotatug deruxtecan has acquired breakthrough remedy designation for therapy of sure adults with platinum-resistant epithelial ovarian most cancers, main peritoneal or fallopian tube cancers that specific CDH6.
Raludotatug deruxtecan (Merck, Daiichi Sankyo) — an investigational, first-in-class CDH6 directed antibody-drug conjugate — acquired FDA breakthrough remedy designation primarily based on knowledge from two scientific trials. The primary is a two-part, first-in-human section 1 trial; the second is the randomized section 2/3 REJOICE-Ovarian01 trial.
The section 1 trial evaluated efficacy and security of raludotatug deruxtecan in 179 adults with superior ovarian most cancers beforehand handled with platinum-based chemotherapy and a taxane.
The primary intention of that research assessed security and tolerability of dose escalation to find out the utmost tolerated dose and/or a beneficial dose for growth, in line with the discharge. The second intention additional evaluated the security and efficacy of the agent in sufferers with superior ovarian most cancers and in sufferers with superior renal cell carcinoma.
The REJOICE-Ovarian01 trial is ready to judge the efficacy and security of raludotatug deruxtecan in roughly 710 sufferers with platinum-resistant, high-grade ovarian main peritoneal or fallopian tube most cancers, with illness development after receiving one to a few prior traces of remedy.
Part 2 of that research goals to establish the beneficial dose between 4.8 mg/kg, 5.6 mg/kg or 6.4 mg/kg, with a main endpoint of goal response charge. Part 3 will assess efficacy and security of the chosen beneficial dose in contrast with investigator’s selection of chemotherapy, with twin main endpoints of ORR and PFS.
“Sufferers have restricted therapy choices as soon as ovarian most cancers turns into proof against platinum-based chemotherapy, highlighting the pressing want for brand new medicines that may enhance affected person outcomes,” Ken Takeshita, MD, international head of analysis and improvement at Daiichi Sankyo, stated within the launch. “The receipt of breakthrough remedy designation represents an necessary 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 bevacizumab.”
