FDA Approves Relacorilant for Platinum-Resistant Ovarian Cancer

The FDA has approved relacorilant (Lifyorli) in combination with nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer.¹

The NDA submission was based on positive data from the pivotal phase 3 ROSELLA trial (NCT05257408) and earlier phase 2 trials.²

The phase 3 ROSELLA trial, evaluating the safety and efficacy of relacorilant plus nab-paclitaxel chemotherapy,³ successfully met its primary end point of overall survival (OS). The data show a 35% reduction in the risk of death, translating to a 4.1-month improvement in median OS compared with nab-paclitaxel alone. Additionally, data show that there was a 30% reduction in the risk of disease progression, meeting the trial’s dual primary end point of progression-free survival (PFS).

The median PFS was 6.54 months (95% CI, 5.55-7.43) in the combination arm vs 5.52 months (95% CI, 3.94-5.88) in the control arm, leading to a hazard ratio (HR) of 0.70 (P =.0076). Six-month and 12-month PFS rates were 52% and 25% in the combination arm compared with 42% and 13% in the control arm, respectively.

Crucially, these substantial efficacy benefits were achieved without increasing the safety burden on patients; the combination therapy's safety profile was comparable to that of chemotherapy alone. The most frequently reported adverse events were known toxicities of nab-paclitaxel: anemia (58%), neutropenia (56%), and nausea (39%).

Relacorilant is an oral therapy and selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body's other hormone receptors. Corcept Therapeutics, developer of the agent, is developing relacorilant in ovarian cancer and a variety of other indications, including endogenous hypercortisolism and prostate cancer. Relacorilant has received orphan drug designation by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of 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 to benefit from this combination…simply the patients that are eligible are those who have been treated for ovarian cancer and who have platinum-resistant ovarian cancer. This is the most exciting thing,” said Alexander Olawaiye, MD, professor in the Department of Obstetrics, Gynecology & Reproductive Sciences at the University of Pittsburgh, in an interview with Targeted Oncology. “It's also very dose convenient, because it's a pill, and so the patient can use the pill in the comfort of their own home and only come into the hospital for the infusion.”

REFERENCES

1. FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. News release. US FDA. March 25, 2026. https://tinyurl.com/2yx5jdfm

2.FDA files Corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics. Published September 10, 2025. Accessed January 26, 2026. https://tinyurl.com/3u39cm5k

3.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 January 26, 2026. https://clinicaltrials.gov/study/NCT05257408