The Food and Drug Administration approved relacorilant (Lifyorli) in combination with nab-paclitaxel for treating adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer on March 25, 2026. The approval applies to patients who have received one to three prior systemic treatment regimens, including at least one with bevacizumab.

Relacorilant is manufactured by Corcept Therapeutics Inc. and functions as a glucocorticoid receptor antagonist. The FDA completed the approval 2.5 months ahead of its goal date.

The approval was based on results from the ROSELLA trial, a multicenter study involving 381 patients with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. Patients were randomized to receive either relacorilant combined with nab-paclitaxel or nab-paclitaxel alone.

The combination therapy demonstrated a median progression-free survival of 6.5 months compared to 5.5 months for nab-paclitaxel alone. Overall survival was 16 months for the combination treatment versus 11.9 months for the single agent.

The recommended dosage is 150 mg of relacorilant taken orally once daily for three consecutive days around each nab-paclitaxel infusion. Nab-paclitaxel is administered at 80 mg/m2 intravenously on days 1, 8, and 15 of each 28-day cycle.

The prescribing information includes contraindications for patients requiring corticosteroids for life-saving indications. Common adverse reactions include decreased hemoglobin and neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

The trial excluded patients requiring chronic or frequent glucocorticoid use and required prior bevacizumab treatment.