FDA Approves Relacorilant Combination Therapy for Platinum-Resistant Ovarian Cancer
On March 25, 2026, the Food and Drug Administration (FDA) approved relacorilant (Lifyorli, Corcept Therapeutics Inc.), a first-in-class selective glucocorticoid receptor antagonist (SGRA), in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. This approval offers a new option for patients who have previously undergone one to three systemic treatment regimens, including at least one course of bevacizumab.
Understanding Platinum-Resistant Ovarian Cancer
Ovarian cancer is often diagnosed at a late stage, making treatment challenging. Platinum-based chemotherapy is a standard first-line treatment, but many patients develop resistance, leading to disease progression. Platinum-resistant ovarian cancer refers to cancer that recurs or does not respond to platinum-based chemotherapy.
How Relacorilant Works
Lifyorli is designed to bind to the glucocorticoid receptor, counteracting the effects of cortisol, a hormone that can suppress the effectiveness of chemotherapy. By inhibiting cortisol’s action, relacorilant aims to enhance the ability of nab-paclitaxel to induce programmed cell death in cancer cells. Fierce Pharma reports that this mechanism is intended to improve chemotherapy sensitivity.
Clinical Trial Results: The ROSELLA Trial
The FDA’s approval is based on the results of the ROSELLA (NCT05257408) trial, a multicenter, open-label study involving 381 patients with platinum-resistant ovarian cancer. Patients in the trial had received one to three prior lines of systemic therapy and prior bevacizumab treatment was required. The trial excluded patients requiring chronic or frequent glucocorticoid use.
Key findings from the ROSELLA trial include:
- Progression-Free Survival (PFS): Median PFS was 6.5 months (95% CI: 5.6, 7.4) with relacorilant plus nab-paclitaxel, compared to 5.5 months (95% CI: 3.9, 5.9) with nab-paclitaxel alone (Hazard ratio 0.70 [95% CI: 0.54, 0.91]; p=0.0076).
- Overall Survival (OS): Median OS was 16 months (95% CI: 13, 18.3) with the combination therapy, versus 11.9 months (95% CI: 10, 13.8) with nab-paclitaxel alone (Hazard ratio 0.65 [95% CI: 0.51, 0.83]; p=0.0004).
These results, as detailed in the FDA’s approval announcement, demonstrate a statistically significant improvement in both PFS and OS with the addition of relacorilant to nab-paclitaxel.
Safety and Side Effects
The prescribing information for Lifyorli includes a contraindication for patients who require corticosteroids for a lifesaving indication. Warnings and precautions include potential risks of neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity.
Availability and Cost
Corcept Therapeutics anticipates making Lifyorli available within one week. The wholesale acquisition cost for a 28-day cycle of therapy is $37,900. The company expects broad coverage from most insurance plans, including Medicare and Medicaid, and has patient assistance programs available. Fierce Pharma reported on these details.
Previous FDA Setback and Future Outlook
This approval follows a Complete Response Letter from the FDA in late 2025 for relacorilant as a treatment for Cushing’s syndrome. Despite the previous setback, Corcept remains committed to exploring relacorilant’s potential in other oncology indications, including endometrial, cervical, pancreatic, and prostate cancers.
“It is a privilege to bring forward a new treatment for patients who historically have had few options,” said Joseph Belanoff, M.D., Corcept’s CEO, in a Business Wire press release. “We have worked for years to demonstrate the potential of cortisol modulation in oncology.”