FDA Approves Lifyorli (Relacorilant) in Combination with Nab-Paclitaxel for Platinum-Resistant Ovarian Cancers
In a significant step forward for gynecologic oncology, the U.S. Food and Drug Administration (FDA) approved relacorilant (brand name Lifyorli) on March 25, 2026. This new treatment is approved for use in combination with nab-paclitaxel to treat adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Lifyorli, developed by Corcept Therapeutics Inc., is the first selective glucocorticoid receptor antagonist to receive FDA approval for this specific patient population. This combination therapy offers a new option for patients who have already undergone multiple systemic treatments and have seen their cancer become resistant to platinum-based therapies.
Who is Eligible for This Treatment?
This approval isn’t for every patient with ovarian cancer. Lifyorli is specifically indicated for adults who meet the following criteria:
- Diagnosis of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Have received one to three prior systemic treatment regimens.
- Must have received at least one prior treatment with bevacizumab.
Understanding the Mechanism: What is a Glucocorticoid Receptor Antagonist?
Relacorilant works as a selective glucocorticoid receptor antagonist. To put it simply, it blocks the receptors that glucocorticoids (stress hormones or steroid medications) bind to. By inhibiting these receptors, Lifyorli aims to enhance the effectiveness of the chemotherapy drug nab-paclitaxel, helping to slow the progression of the disease in patients who no longer respond to platinum-based drugs.
The Evidence: Results from the ROSELLA Trial
The FDA’s decision was based on data from the ROSELLA trial (NCT05257408), a multicenter, open-label study involving 381 patients. The trial compared the combination of relacorilant and nab-paclitaxel against nab-paclitaxel alone. The results showed a statistically significant improvement in both progression-free survival (PFS) and overall survival (OS).
Progression-Free Survival (PFS)
Patients receiving the combination therapy experienced a median PFS of 6.5 months, compared to 5.5 months for those receiving nab-paclitaxel alone (Hazard ratio 0.70; p-value 0.0076).
Overall Survival (OS)
The impact on overall survival was even more pronounced. The median OS for the relacorilant and nab-paclitaxel group was 16 months, while the nab-paclitaxel alone group had a median OS of 11.9 months (Hazard ratio 0.65; p-value 0.0004).
Dosage and Administration
Lifyorli is an oral medication. According to the FDA recommended dosage, patients take 150 mg orally once on three specific days:
- The day before a nab-paclitaxel infusion.
- The day of the infusion.
- The day after the infusion.
This cycle continues until the disease progresses or the patient experiences unacceptable toxicity.
Safety, Warnings, and Contraindications
While Lifyorli provides a new therapeutic path, it carries specific safety warnings that patients and providers must consider.
Contraindications
Lifyorli is strictly contraindicated for patients who require corticosteroids for a lifesaving indication.
Key Warnings and Precautions
- Adrenal Insufficiency: Given that the drug blocks glucocorticoid receptors, it can lead to adrenal insufficiency.
- Infections: There are warnings regarding neutropenia and the risk of severe infections.
- Condition Exacerbation: The drug may worsen conditions that are typically treated with glucocorticoids.
- Embryo-Fetal Toxicity: Caution is required regarding potential risks to a fetus.
Key Takeaways
- New Approval: Lifyorli (relacorilant) is now FDA-approved for use with nab-paclitaxel.
- Target Group: Adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Requirement: Patients must have had 1-3 prior systemic therapies, including bevacizumab.
- Clinical Benefit: The ROSELLA trial showed an increase in median overall survival from 11.9 to 16 months.
- Administration: 150 mg oral dose taken the day before, day of, and day after each infusion.
Looking Ahead
The approval of Lifyorli represents a targeted approach to overcoming chemotherapy resistance in advanced gynecologic cancers. By modulating the glucocorticoid receptor, clinicians now have a tool to potentially extend the lives of patients who have exhausted standard platinum-based options. As with all new approvals, real-world data will continue to refine how this combination is used in clinical practice.
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