FDA Approves Relacorilant With Nab-Paclitaxel for Adults With Specific Ovarian, Fallopian Tube, or Peritoneal Cancers

The FDA has approved relacorilant (Lifyorli; Corcept Therapeutics Inc) in combination with nab-paclitaxel (Abraxane; Bristol Myers Squibb) for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Specifically, the indication is for those who have received 1 to 3 prior systemic treatment regimens, of which at least 1 includes bevacizumab (Avastin; Genentech).¹

Relacorilant is a glucocorticoid receptor agonist. The FDA states that the recommended dosage is 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion until disease progression or unacceptable toxicity. For nab-paclitaxel, the recommended dosage is 80 mg/m² administered intravenously on days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.¹

Clinical Findings Supporting Relacorilant’s Approval

The safety and efficacy of relacorilant were evaluated in the randomized, controlled, open-label, multicenter phase 3 trial ROSELLA (NCT05257408)². The trial enrolled 381 patients between January 5, 2023, and April 8, 2024, with platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancer who had received up to 3 prior lines of anticancer therapy and previous bevacizumab therapy, and who had disease progression or intolerance to their most recent therapy.^2,3

Patients were randomly assigned to receive either relacorilant with nab-paclitaxel (n = 188) or nab-paclitaxel monotherapy (n = 193). The trial’s dual primary end points were progression-free survival (PFS) assessed by blinded independent central review per RECIST 1.1 and overall survival (OS), and they were assessed in all randomly assigned patients by intention to treat. Additionally, the safety population included all randomly assigned patients who received at least 1 dose of the assigned treatment. Results were published in The Lancet in June 2025.^2,3

According to the study findings, patients who received treatment with relacorilant plus nab-paclitaxel had a statistically significant improvement in median PFS (6.54 months [95% CI, 5.55-7.43]) compared with those receiving nab-paclitaxel monotherapy (5.52 months [95% CI, 3.94-5.88]; HR, 0.70 [95% CI, 0.54-0.91]; stratified log-rank P = .0076). At the planned interim analysis, the investigators observed a clinically meaningful difference in OS when relacorilant was added to nab-paclitaxel (15.97 months [95% CI, 13.47-not reached]) compared with nab-paclitaxel alone (11.50 months [10.02-13.57]; 0.69 [95% CI, 0.52-0.92]; log-rank P = .0121).³

Safety and Adverse Events

Of note, adverse events (AEs) were similar across study groups when adjusted for nab-paclitaxel exposure, and no new safety signals were observed. The most common AEs (incidence, ≥ 20%), including laboratory abnormalities, that occurred in patients treated with relacorilant plus nab-paclitaxel were rash, fatigue, nausea, and diarrhea; decreased hemoglobin, neutrophil, and platelet levels; and decreased appetite.¹

For nab-paclitaxel, results published in the Journal of Clinical Oncology and presented at the 2025 American Society of Clinical Oncology Annual Meeting showed that the most frequently reported AEs were known nab-paclitaxel toxicities, including anemia (58%), neutropenia (56%), and nausea (39%).⁴

According to the FDA, the prescribing information includes a contraindication for patients who require corticosteroids for a lifesaving indication as well as warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity.¹

REFERENCES

1. FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. FDA. March 25, 2026. Accessed March 25, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or

2. Relacorilant in combination with nab-paclitaxel in advanced, platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. ClinicalTrials.gov. Updated April 16, 2025. Accessed March 25, 2026. https://clinicaltrials.gov/study/NCT05257408

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. 2025;405(10496):2205-2216. doi:10.1016/S0140-6736(25)01040-2

4. 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