FDA
FDA approves Lifyorli plus nab-paclitaxel for platinum-resistant ovarian cancer
Brand name: Lifyorli
Generic name: relacorilant
Manufacturer: Corcept Therapeutics Inc.
Approval date: March 25, 2026
FDA approved Lifyorli (relacorilant), an oral glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who've received one to three prior systemic regimens, at least one of which included bevacizumab.
Efficacy
Efficacy was evaluated in ROSELLA (NCT05257408), a multicenter, open-label, trial involving 381 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who'd received up to three prior lines of systemic therapy. Prior bevacizumab treatment was required. The trial excluded patients who required chronic or frequent use of glucocorticoids. Participants were randomized 1:1 to receive relacorilant in combination with nab-paclitaxel or nab-paclitaxel alone.
The two primary endpoints were progression-free survival (PFS) and overall survival (OS). Median PFS 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-value 0.0076). Median OS 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-value 0.0004).
Safety
The most common adverse reactions (≥ 20%) in patients treated with relacorilant plus nab-paclitaxel were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite. The prescribing information for Lifyorli 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.
Recommended Dose
The recommended dosage of Lifyorli (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 IV infusion on days 1, 8 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Sources:
(2026, March 25). FDA Approves Corcept’s Selective Glucocorticoid Receptor Antagonist Lifyorli™ (relacorilant) Plus Nab-Paclitaxel for Treatment of Patients with Platinum-Resistant Ovarian Cancer. [Press release]. Corcept Therapeutics Inc. https://ir.corcept.com/news-releases/news-release-details/fda-approves-corcepts-selective-glucocorticoid-receptor
(2026, March 25). FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. [News release]. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
Lifyorli (relacorilant). [Package insert]. Corcept Therapeutics Inc. https://corcept.com/wp-content/uploads/Lifyorli_PI.pdf Dated March 2026. Accessed March 26, 2026.
