The U.S. Food and Drug Administration (FDA) has opened a new door in the fight against platinum-resistant ovarian cancer: the combination of relacorilant, a glucocorticoid receptor antagonist, with nab-paclitaxel has been officially approved.
March 25, 2026 — The FDA approved the combination of relacorilant (Lifyorli) with nab-paclitaxel for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who had previously received 1 to 3 systemic treatment regimens, at least one of which contained bevacizumab.
Relacorilant is a novel agent that targets the glucocorticoid receptor, which plays a role in the resistance mechanisms cancer cells develop against chemotherapy. Used together with nab-paclitaxel, it aims to delay disease progression compared with chemotherapy alone.
The Study Behind the Approval: ROSELLA (Phase 3)
The approval is based on data from the multicenter, open-label Phase 3 ROSELLA (NCT05257408) clinical trial, conducted with a total of 381 patients. Patients receiving the relacorilant combination showed a marked improvement in two key survival measures compared with the group receiving nab-paclitaxel alone:
- Progression-Free Survival (PFS): median of 6.5 months in the combination arm versus 5.5 months in the nab-paclitaxel-alone arm.
- Overall Survival (OS): median of 16 months in the combination arm versus 11.9 months in the nab-paclitaxel-alone arm.
💬 Why Does This Approval Matter?
Platinum-resistant ovarian cancer is a patient group with limited treatment options and difficult survival outcomes. By both delaying disease progression and extending overall survival, the relacorilant and nab-paclitaxel combination offers a new treatment option for these patients, who have already received multiple prior therapies including bevacizumab.
Important Warnings and Contraindications
This treatment regimen is contraindicated in patients who require corticosteroids, except in life-threatening situations. The main warnings in the prescribing information are:
- Neutropenia
- Serious infections
- Adrenal insufficiency
- Embryo-fetal toxicity
Common Side Effects
The most common (>20%) side effects observed include:
- Decreases in hemoglobin, neutrophil and platelet counts
- Fatigue
- Nausea and diarrhea
- Rash
- Loss of appetite
Conclusion
With this approval, relacorilant takes its place as an option with a new mechanism of action in the treatment of platinum-resistant ovarian cancer. Physicians should carefully assess the patient's need for corticosteroids and overall clinical condition before starting therapy.