Shares of Corcept Therapeutics (NASDAQ:CORT) surged about 40% on Wednesday after the U.S. Food and Drug Administration (FDA) approved relacorilant (Lifyorli) in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The approval covers patients who have previously undergone one to three systemic treatment regimens, including at least one therapy involving bevacizumab. The FDA granted the authorization roughly two and a half months ahead of its scheduled decision date.
The decision was supported by findings from the ROSELLA trial, a multicenter study involving 381 patients diagnosed with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. Participants in the study were randomly assigned to receive either relacorilant combined with nab-paclitaxel or nab-paclitaxel alone.
Results showed that patients receiving the combination therapy achieved a median progression-free survival of 6.5 months, compared with 5.5 months for those treated with nab-paclitaxel alone. The combination also improved overall survival, which reached 16 months, versus 11.9 months for the single-agent treatment.
Relacorilant works as a glucocorticoid receptor antagonist. The recommended dosing regimen is 150 mg taken orally once daily for three consecutive days around each nab-paclitaxel infusion, while nab-paclitaxel is administered intravenously at 80 mg/m² on days 1, 8, and 15 of a 28-day treatment cycle.
According to the prescribing information, the therapy is contraindicated for patients who require corticosteroids for life-saving indications. Frequently reported adverse reactions include reduced hemoglobin and neutrophil levels, fatigue, nausea, diarrhea, lower platelet counts, rash, and decreased appetite.