FDA Approval of Relacorilant and Nab-Paclitaxel in Platinum-Resistant Ovarian Cancer
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FDA Approval of the Relacorilant + Nab-Paclitaxel Combination in Ovarian Cancer: Analysis of the ROSELLA Trial
The new approach, which overcomes chemotherapy resistance through cortisol modulation, reduced the risk of mortality by 35% in platinum-resistant disease.
Clinical Indication and Patient Eligibility
On March 25, 2026, the FDA approved relacorilant (Lifyorli) with nab-paclitaxel as a combination for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. This treatment option can be used in all eligible patients diagnosed with platinum-resistant disease without requiring any biomarker testing, such as a search for genetic mutations.
- Biomarker-Independent: No special test is required for eligibility.
- Ease of Administration: Relacorilant is taken orally as a pill; patients can complete this part of their treatment in the comfort of their own homes.
- Safety Profile: Adding relacorilant to chemotherapy did not cause a significant increase in the burden of adverse effects.
ROSELLA Phase III: Analysis of Clinical Data
The approval decision is based on data from the pivotal ROSELLA Phase III trial, which demonstrated superiority in both overall survival (OS) and progression-free survival (PFS):
%35
Improvement in Overall Survival (OS)
%30
Risk of Disease Progression (PFS)
The data showed a net improvement in overall survival of 4.1 months compared with the control arm. In addition, the 12-month PFS rate in the combination arm was %25 while it remained at 13% in the control arm.
Mechanism of Action and Safety
Relacorilant is a selective glucocorticoid receptor (GR) antagonist. By modulating cortisol activity, it suppresses the survival signals that cancer cells develop against chemotherapy.
| Adverse Effect (Mostly Attributable to Nab-Paclitaxel) | Frequency |
|---|---|
| Anemia | %58 |
| Neutropenia | %56 |
| Nausea | %39 |
Achieving a 4-month improvement in overall survival in platinum-resistant disease is a “revolutionary” result in gynecologic oncology practice. Relacorilant’s greatest achievement is its ability to potentiate chemotherapy without adding an extra toxicity burden for the patient.
Approval of this oral treatment targeting the cortisol pathway is the clearest evidence that generic chemotherapies can be revitalized with biological modulators.
Scientific Sources
- FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. March 25, 2026.
- Relacorilant in combination with nab-paclitaxel in advanced, platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. ClinicalTrials.gov (NCT05257408).
- Corcept Therapeutics Press Release: ROSELLA Trial Efficacy Data Analysis.
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