FDA Accepts New Drug Application for Relacorilant as a Treatment for Patients With Platinum-Resistant Ovarian Cancer
The US Food and Drug Administration has accepted a New Drug Application for relacorilant, an oral, selective glucocorticoid receptor antagonist (SGRA), as a treatment for patients with platinum-resistant ovarian cancer (PROC).
This New Drug Application is based on data from the phase 3 ROSELLA trial, as well as phase 2 trials.
In the randomized, open-label, global ROSELLA trial, 381 patients with PROC. Patients were randomized on a 1-to-1 basis to receive either relacorilant plus nab-paclitaxel (n = 188) or nab-paclitaxel alone (n = 193). The dual primary end points were progression-free survival (PFS) by blinded independent central review and overall survival (OS), with secondary end points including PFS by investigator, objective response rate (ORR), best overall response, duration of response, and safety.
The median PFS by blinded independent central review in the relacorilant arm was 6.5 months compared to 5.5 months in the nab-paclitaxel alone arm (hazard ratio [HR], 0.07; P = .008). This represents a statistically significant improvement to PFS in the relacorilant arm. The median OS was 16.0 months in the relacorilant arm compared to 11.5 months in the nab-paclitaxel arm (HR, 0.69; P = .01), representing a clinically meaningful improvement in the relacorilant arm.
The most common adverse events, including anemia, neutropenia, and nausea, are known toxicities of nab-paclitaxel and were similar across study groups. As a press release from Corcept Therapeutics Incorporated stated, “relacorilant conferred its benefit without increasing the safety burden of the patients who received it.”
Of the ROSELLA trial, Alexander Olawaiye, MD, University of Pittsburgh, Pennsylvania, and coauthors, concluded, “relacorilant plus nab-paclitaxel is the first treatment regimen to demonstrate a PFS and OS benefit in patients with PROC compared to a weekly taxane, the most efficacious comparator.” They also noted this data suggests the regimen “as a new standard for patients with PROC, without the need for biomarker selection.”
The press release noted that the Prescription Drug User Fee Act (PDUFA) date assigned for relacorilant is July 11, 2026.
Sources:
Olawaiye A, Gladieff L, Gilbert L, et al. ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). J Clin Oncol. Published on June 4, 2025. doi:10.1200/JCO.2025/43.17_suppl.LBA5507.
FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer. Corcept Therapeutics Incorporated. Published on September 10, 2025. Accessed on September 10, 2025. https://ir.corcept.com/news-releases/news-release-details/fda-files-corcepts-new-drug-application-relacorilant-treatment-0
