The FDA has approved Corcept Therapeutics’ Lifyorli (relacorilant) in combination with nab-paclitaxel for adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer, based on positive survival results from the Phase 3 ROSELLA trial.
Written By: Anand Sathappan, BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration approved Lifyorli™ (relacorilant) on March 25, 2026, developed by Corcept Therapeutics, in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic regimens, including at least one with bevacizumab. This marks the first selective glucocorticoid receptor antagonist (SGRA) approved in oncology.
Relacorilant selectively blocks the glucocorticoid receptor, a pathway implicated in tumor progression and chemotherapy resistance. By modulating cortisol signaling, it enhances cytotoxic agents like nab-paclitaxel in advanced disease.
The approval is based on results from the pivotal ROSELLA trial (NCT05257408), which enrolled 381 patients with platinum-resistant ovarian cancer who had received one to three prior lines of therapy. Participants were randomized to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The study met its dual primary endpoints of progression-free survival and overall survival. Patients receiving the combination therapy experienced a 35% reduction in the risk of death compared with chemotherapy alone (hazard ratio 0.65; p=0.0004). Median overall survival reached 16.0 months with the combination versus 11.9 months with nab-paclitaxel alone.
The combination also demonstrated a 30% reduction in the risk of disease progression (hazard ratio 0.70; p=0.008) based on blinded independent central review. No biomarker selection was required for enrollment, suggesting broad applicability of the therapy in this difficult-to-treat population.
Safety was manageable; pooled ROSELLA/Phase 2 data showed common adverse reactions (>20%) including decreased hemoglobin, neutropenia, fatigue, nausea, diarrhea, thrombocytopenia, rash, and decreased appetite. Warnings cover neutropenia, severe infections, adrenal insufficiency, exacerbation of glucocorticoid-treated conditions, and embryo-fetal toxicity.
Dr. Rob Coleman, Texas Oncology and Special Advisor to the President of the GOG Foundation, and Joseph Belanoff, M.D., Chief Executive Officer of Corcept Therapeutics, highlighted the significance of the FDA approval, noting that the combination of Lifyorli (relacorilant) and nab-paclitaxel demonstrated a clinically meaningful improvement in overall survival for patients with platinum-resistant ovarian cancer and was generally well tolerated. They emphasized that the therapy could represent an important new treatment option for patients with this difficult-to-treat disease and marks a key step in advancing cortisol modulation as a novel approach in oncology.
The ROSELLA trial was conducted across multiple global regions including the United States, Europe, South Korea, Brazil, Argentina, Canada, and Australia, in collaboration with several international gynecologic oncology research networks. Full results were first presented at the 2025 American Society of Clinical Oncology (ASCO) meeting and published in The Lancet, with additional data expected to be presented at the Society of Gynecologic Oncology (SGO) meeting.
Platinum-resistant ovarian cancer recurrence ≤6 months post-platinum—poses major challenges with poor prognosis. ~20,000 US women yearly qualify for new therapies, similarly in Europe.
References
FDA Approves Corcept’s Selective Glucocorticoid Receptor Antagonist Lifyorli™ (relacorilant) Plus Nab-Paclitaxel for Treatment of Patients with Platinum-Resistant Ovarian Cancer, 25 March 2026, FDA Approves Corcept’s Selective Glucocorticoid Receptor Antagonist Lifyorli™ (relacorilant) Plus Nab-Paclitaxel for Treatment of Patients with Platinum-Resistant Ovarian Cancer – Corcept Therapeutics, Incorporated
Olawaiye A, Gladieff L, O’Malley D et al., Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial, The Lancet, 2025, 405, 2205-2216, https://doi.org/10.1016/S0140-6736(25)01040-2
Relacorilant in Combination with Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer, ClinicalTrials.gov ID NCT05257408, Study Details | NCT05257408 | Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer | ClinicalTrials.gov
About the Writer
Anand Sathappan is a pharmacy graduate with interests in pharmaceutical sciences, pharmacology, and medical writing. He also holds certification in medical coding and has familiarity with pharmacology and healthcare documentation. He has completed the Medical Writing Skills for Beginners program offered by the International Medical Writers Association (IMWA). His work focuses on exploring developments in pharmaceuticals and presenting scientific information in a clear and structured manner.