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Joyce F. Liu, MD, MPH
Joyce F. Liu, MD, MPH
Posted: Thursday, March 26, 2026
On March 25, 2026, the U.S. Food and Drug Administration approved the glucocorticoid receptor antagonist relacorilant (Lifyorli) in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.
Efficacy
Efficacy was evaluated in ROSELLA (ClinicalTrials.gov identifier NCT05257408), a multicenter, open-label, phase III trial that enrolled 381 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients were permitted to receive up to three prior lines of systemic therapy and prior bevacizumab was required. The trial excluded patients who required chronic or frequent use of glucocorticoids. Patients were randomly assigned (1:1) to receive relacorilant plus nab-paclitaxel or nab-paclitaxel alone.
The major efficacy outcome measures were progression-free survival assessed by blinded independent central review according to RECIST version 1.1 and overall survival. Median progression-free survival was 6.5 months (95% confidence interval [CI] = 5.6–7.4) in the relacorilant plus nab-paclitaxel arm and 5.5 months (95% CI = 3.9–5.9) in the nab-paclitaxel arm (hazard ratio [HR] = 0.70, 95% CI = 0.54–0.91; two-sided P = .0076). Median overall survival was 16 months (95% CI = 13–18.3) in the relacorilant plus nab-paclitaxel arm and 11.9 months (95% CI = 10–13.8) in the nab-paclitaxel arm (HR = 0.65, 95% CI = 0.51–0.83; two-sided P = .0004).
Safety
The prescribing information includes a contraindication for patients who require corticosteroids for a lifesaving indication as well as warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity.
The most common adverse reactions (incidence ≥ 20%), including laboratory abnormalities, that occurred in patients treated with relacorilant plus nab-paclitaxel were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.
Recommended Dosage
The recommended dosage of relacorilant is 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion until disease progression or unacceptable toxicity. The recommended dosage for nab-paclitaxel is 80 mg/m2 administered as an intravenous infusion on days 1, 8 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
U.S. Food and Drug Administration
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