FDA Accepts Relacorilant NDA for Platinum-Resistant Ovarian Cancer

The FDA has accepted a new drug application (NDA) to relacorilant for the treatment of patients with platinum-resistant ovarian cancer, according to a news release from Corcept Therapeutics, the drug’s developer.¹

With the acceptance of the NDA, the FDA assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026, meaning the FDA plans to make a regulatory decision on this indication by that point.

The NDA’s acceptance is based on positive data from the phase 3 ROSELLA trial (NCT05257408) as well as from a previous phase 2 trial (NCT03776812), which investigated the selective glucocorticoid receptor antagonist in combination with nab-paclitaxel (Abraxane).

Notably, relacorilant does not require biomarker selection and is an oral therapy, potentially representing a convenient option for patients with ovarian cancer.

“The use of relacorilant combined with nab-paclitaxel does not require biomarker selection, which means there is no special testing that needs to be done for a patient to be eligible for this combination when it becomes available,” explained Alexander Olawaiye, MD, who shared ROSELLA data at the 2025 American Society of Clinical Oncology Annual Meeting, in an interview with Oncology Nursing News.

Olawaiye, a professor of gynecologic oncology at the University of Pittsburgh and Magee-Women’s Hospital of UPMC in Pittsburgh, Pennsylvania, was a primary investigator of the trial.

How Effective and Safe is Relacorilant?

Data from the ROSELLA trial was most recently presented at the 2025 ESMO Gynecological Cancers Congress and prior to that at the 2025 ASCO Annual Meeting. These data were simultaneously published in The Lancet.^2,3,4

Findings demonstrated a median progression-free survival (PFS) via blinded independent central review (BICR) was 6.54 months (95% CI, 5.55-7.43) and 5.52 months (95% CI, 3.94-5.88) in combination therapy (n = 188) and monotherapy (n = 193) arms, respectively. This yielded a 30% decrease in risk of disease progression or death (HR, 0.70; 95% CI, 0.54-0.91; P = .0076).

Six-month PFS rates were 52% for those taking relacorilant with nab-paclitaxel compared with 42% in those receiving nab-paclitaxel alone. Likewise, 1-year PFS rates were 25% and 13%, respectively.

Regarding safety, treatment-emergent adverse effects (TEAEs) occurred in all but 1 patient in the overall ROSELLA patient population. TEAEs grade 3 or higher occurred in 74.5% of patients receiving relacorilant/nab-paclitaxel.

The most common any-grade TEAEs included neutropenia (relacorilant arm, 64%; nab-paclitaxel arm, 49%), anemia (61%; 55%), nausea (44%; 35%), diarrhea (39%; 27%), constipation (32%; 27%), abdominal pain (29%; 28%), vomiting (26%; 23%), decreased appetite (22%; 12%), fatigue (53%; 45%), and alopecia (38%; 31%).

TEAEs caused dose reductions in 6.9% of patients receiving combination therapy. Treatment interruptions to either regimen as a result of TEAEs occurred in 72.9% of patients. Additionally, 9.0% of patients in each arm discontinued treatment due to TEAEs.

Relacorilant’s Performance in Poor-Prognosis Subgroups

Results presented at the 2025 ESMO Gynecological Cancers Congress also demonstrated that survival outcomes for patients receiving relacorilant/nab-paclitaxel combination therapy outperformed those for patients receiving nab-paclitaxel alone in poor-prognosis subgroups.⁴

For patients with a platinum-free interval of 1 to 6 months, the combination yielded a median PFS of 5.82 months (95% CI, 5.29-7.89) vs 3.94 months (95% CI, 2.73-5.78) in combination and monotherapy arms, respectively (n = 58; HR, 0.50; 95% CI, 0.30-0.84; nominal P = .0081).

Additionally in this patient population, relacorilant/nab-paclitaxel achieved an unreached median overall survival (NR; 95% CI, 8.44-NR) vs 9.56 months (95% CI, 6.05-11.50) in patients receiving nab-paclitaxel monotherapy (HR, 0. 52; 95% CI, 0.31-0.89; nominal P = .0140).

While relacorilant does not require biomarker testing, patients with BRCA1/2-mutated disease did not experience a PFS improvement.

References

1. FDA files corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. Corcept Therapeutics. News release. September 10, 2025. Accessed September 10, 2025. https://ir.corcept.com/news-releases/news-release-details/fda-files-corcepts-new-drug-application-relacorilant-treatment-0
2. 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. 2025;43(suppl 17):LBA5507. doi:10.1200/JCO.2025.43.17_suppl.LBA5507
3. Olawaiye AB, Gladieff L, O’Malley DM, et al. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. Lancet. Published online June 2, 2025. doi:10.1016/S0140-6736(25)01040-2
4. Lorusso D, Gladieff L, Gilbert L, et al. Phase III results of relacorilant + nab-paclitaxel vs nab-paclitaxel in platinum-resistant ovarian cancer (PROC) (ROSELLA, GOG-3073, ENGOT-ov72): Secondary endpoints. Presented at: 2025 ESMO Gynecological Cancer Congress; June 19-21, 2025; Vienna, Austria. Abstract 70O.