FDA Approves Lifyorli (relacorilant) for Platinum-Resistant Ovarian Cancer on March 25

The U.S. Food and Drug Administration approved relacorilant (Lifyorli) on March 25, 2026, for use with nab-paclitaxel in adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, officials said. The approval was based on the phase 3 ROSELLA trial, which showed that the combination significantly improved progression-free survival compared to nab-paclitaxel alone.

The approval was based on results from the phase 3 ROSELLA trial (NCT05257408), a multicenter, open-label study involving 381 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, according to FDA documents. Patients enrolled in the trial had received one to three prior systemic treatment regimens, including at least one containing bevacizumab (Avastin). Participants were randomized 1:1 to receive either relacorilant in combination with nab-paclitaxel (Abraxane) or nab-paclitaxel alone.

The trial demonstrated a significant improvement in median progression-free survival (PFS) for patients treated with the combination therapy.

Median PFS was 6.5 months (95% confidence interval [CI], 5.6 to 7.4) with relacorilant plus nab-paclitaxel, compared to 5.5 months (95% CI, 3.9 to 5.9) for nab-paclitaxel monotherapy. The hazard ratio (HR) for disease progression or death was 0.70 (95% CI, 0.54 to 0.91; P=0.0076), indicating a 30% reduction in risk with the combination treatment, according to trial data submitted to the FDA.

In addition to PFS benefits, the ROSELLA trial showed a significant overall survival (OS) advantage. Median OS was 16 months (95% CI, 13 to 18.3) for patients receiving relacorilant plus nab-paclitaxel, compared with 11.9 months (95% CI, 10 to 13.8) for those on nab-paclitaxel alone. The HR for death was 0.65 (95% CI, 0.51 to 0.83; two-sided P=0.0004), reflecting a 35% reduction in mortality risk with the combination therapy, according to FDA evaluation documents.

Relacorilant is a selective glucocorticoid receptor antagonist developed by Corcept Therapeutics Inc., which manufactures Lifyorli. The drug is administered at a recommended dose of 150 mg once daily on the day before, day of, and day after nab-paclitaxel infusion. Nab-paclitaxel is dosed at 80 mg per square meter on days 1, 8, and 15 of each 28-day treatment cycle. Treatment continues until disease progression or unacceptable toxicity occurs, officials said. The combination is specifically approved for use with nab-paclitaxel in the indicated patient population.

Safety data from the ROSELLA trial indicated that the most common adverse reactions associated with the combination therapy included decreased hemoglobin, decreased neutrophils, fatigue, nausea, and diarrhea. Although specific incidence rates were not detailed in the FDA approval announcement, the safety profile was consistent with previously reported clinical trial data. Patients in the study were monitored closely for toxicity throughout treatment, and the trial excluded individuals requiring chronic or frequent glucocorticoids.

The FDA’s approval of Lifyorli occurred more than three months ahead of the Prescription Drug User Fee Act (PDUFA) target date of July 11, 2026, according to agency records. Corcept Therapeutics submitted the new drug application in September 2025. Following approval, Lifyorli became available for eligible patients in the United States alongside nab-paclitaxel.

Experts have noted the significance of this approval in the treatment landscape for platinum-resistant ovarian cancer. Rob Coleman, a gynecologic oncologist at Texas Oncology, described Lifyorli as a first-in-class drug with the potential to establish a new standard of care. Jasminemay Barcelon, a senior oncology analyst at GlobalData, highlighted the drug’s ability to potentially resensitize tumors to chemotherapy without requiring glucocorticoid receptor expression, based on the clinical data.

Full prescribing information for Lifyorli is available on the FDA’s Drugs@FDA database. The FDA’s decision was supported by comprehensive review of efficacy and safety data from the ROSELLA trial, which enrolled patients with refractory, platinum-resistant disease who had previously received bevacizumab and up to three systemic therapies. The approval marks a new treatment option for a patient population with limited alternatives.