FDA decision on relacorilant for ovarian cancer expected in July
Agency to review Corcept's application to treat platinum-resistant disease
The U.S. Food and Drug Administration (FDA) has agreed to review Corcept Therapeutics’ application seeking approval of relacorilant to treat platinum-resistant ovarian cancer.
The FDA is set to make a final decision on the application by July 11, 2026, according to the company.
“The FDA’s acceptance of our NDA [new drug application] brings us closer to offering a much-needed treatment option to patients with this dire disease,” Joseph Belanoff, MD, CEO of Corcept, said in a company press release.
Ovarian cancer is a form of gynecological cancer marked by abnormal cell growth around the ovaries and fallopian tubes. Platinum-based chemotherapies are a standard treatment for ovarian cancer, but for patients whose tumors are resistant to platinum agents, options are limited.
Redefining treatment
Cortisol is a hormone naturally produced by the body in response to stress. In ovarian cancer, cortisol binding to receptors on cancer cells can help promote the cells’ resistance to chemotherapies. Relacorilant is designed to block cellular receptors for cortisol and help make ovarian cancer more sensitive to chemotherapy.
“Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated,” Belanoff said.
Corcept is also developing relacorilant to treat endogenous Cushing’s syndrome, a condition where levels of the stress hormone cortisol are too high. An application for approval in that indication is under FDA review, with a decision expected in December.
Corcept’s application seeking approval of relacorilant for ovarian cancer was based in large part on data from the Phase 3 ROSELLA clinical trial (NCT05257408). The study enrolled adults with platinum-resistant ovarian cancer who had received at least one prior line of treatment. All of the patients received a standard chemotherapy regimen called nab-paclitaxel, and some also received relacorilant.
Results from ROSELLA, published earlier this year, showed that the risk of disease progression or death was significantly reduced, by about 30%, in patients who received relacorilant. After one year, 60% of patients given relacorilant were still alive, compared with 49% of patients given chemotherapy alone. Safety data were comparable for patients given relacorilant or chemotherapy alone.
Corcept’s application includes data from earlier Phase 2 studies.
The company is running an open-label Phase 2 trial called BELLA (NCT06906341) testing relacorilant in combination with nab-paclitaxel and the antibody-based therapy bevacizumab to treat adults with platinum-resistant ovarian cancer. That trial is recruiting participants at sites in the U.S., Europe, and South Korea.
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