FDA Approves Relacorilant Combo in Platinum-Resistant Ovarian Cancers

The FDA has approved relacorilant (Lifyorli) plus nab-paclitaxel (Abraxane) as a treatment for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer that is platinum-resistant and has been treated by 1 to 3 prior systemic regimens, one of which including bevacizumab (Avastin).¹

Supporting results for the approval come from the phase 3 ROSELLA trial (NCT05257408). Relacorilant plus nab-paclitaxel achieved a median progression-free survival (FPS) of 6.5 months (95% CI, 5.6-7.4) vs 5.5 months (95% CI, 3.9-5.9) in the nab-paclitaxel alone arm (HR, 0.70; 95% CI, 0.54-0.91; P = .0076). The median overall survival (OS) was 16 months (95% CI, 13.0-18.3) vs 11.9 months (95% CI, 10.0-13.8), respectively (HR, 0.65; 95% CI, 0.51-0.83; P = .0004).

Previously, full results from ROSELLA were shared at the 27th European Gynaecological Oncology Congress.²

“If you follow the ovarian cancer space for any duration in time, you know that the unmet need is that we need more regimens in patients who develop [platinum]-resistant disease,” said Robert L. Coleman, MD, FACOG, FACS, a gynecologic oncologist at Texas Oncology, in a conversation with CancerNetwork after the approval. “This fills a great need for us in that patient population.”

The recommended dose is relacorilant at 150 mg orally and nab-paclitaxel at 80 mg/m² administered as an intravenous infusion. Nab-paclitaxel is given on days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity, and relacorilant is given once on the day before, the day of, and the day after each nab-paclitaxel infusion.

Eligible patients in the trial had platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, and had received up to 3 prior lines of systemic therapy, including prior bevacizumab. Those with chronic or frequent use of corticosteroids were ineligible for enrollment.

The FDA has included a contraindication in the label for patients who require corticosteroids for a livesaving indication, as well as warnings for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal conditions.

Regarding safety, the most common adverse reactions with the newly approved regimen were decreased hemoglobin, decreased neutrophils, fatigue, nausea, and diarrhea, among others.

Additionally, the FDA accepted a new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer in September 2025.³

References

1. FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. News release. FDA. March 25, 2026. Accessed March 25, 2026. https://tinyurl.com/yrxh4y8w
2. Lorusso D, Quesada S, Chan JK, et al. ROSELLA: a phase 3 study of relacorilant + nab-paclitaxel in patients with platinum-resistant ovarian cancer. Presented at: European Society of Gynaecological Oncology 2026 Congress; February 26-28, 2026; Copenhagen, Denmark.
3. FDA files Corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics Inc. September 10, 2025. Accessed March 25, 2026. https://tinyurl.com/5yx7cbsp