What Was Approved?
On March 25, 2026, the U.S. Food and Drug Administration approved Lifyorli (relacorilant) in combination with nab-paclitaxel for adults with:
- Platinum-resistant epithelial ovarian cancer
- Fallopian tube cancer
- Primary peritoneal cancer
Patients must have received one to three prior systemic treatment regimens, including at least one regimen containing bevacizumab.
How Does Lifyorli Work?
Lifyorli is a glucocorticoid receptor antagonist.
It is used with nab-paclitaxel and is intended to interfere with glucocorticoid receptor signaling that may contribute to resistance to chemotherapy.
How Is Lifyorli Taken?
The recommended dose is:
150 mg by mouth once daily on the day before, the day of, and the day after each nab-paclitaxel infusion.
Nab-paclitaxel is administered intravenously on Days 1, 8, and 15 of each 28-day cycle.
What Did the Clinical Trial Show?
FDA evaluated Lifyorli in the ROSELLA trial involving 381 patients.
Median progression-free survival was:
- 6.5 months with Lifyorli plus nab-paclitaxel
- 5.5 months with nab-paclitaxel alone
Median overall survival was:
- 16 months with the combination
- 11.9 months with nab-paclitaxel alone
These results describe the study population and do not guarantee the same outcome for every patient.
What Are the Main Safety Concerns?
The FDA-approved label includes warnings for:
- Neutropenia and serious infections
- Adrenal insufficiency
- Worsening of conditions that require glucocorticoid treatment
- Embryo-fetal toxicity
Lifyorli is contraindicated in patients who require systemic corticosteroids for a lifesaving indication.
What Are Common Side Effects?
Common adverse reactions and laboratory abnormalities included:
- Low hemoglobin
- Low neutrophil counts
- Fatigue
- Nausea
- Diarrhea
- Low platelet counts
- Rash
- Decreased appetite
Bottom Line
Lifyorli (relacorilant) is a newly FDA-approved oral medicine used with nab-paclitaxel for certain adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer after prior treatment that included bevacizumab.
Because it can affect glucocorticoid activity and increase the risk of infection and other serious adverse effects, treatment requires oncology supervision and appropriate monitoring.
Sources
- U.S. Food and Drug Administration (FDA) — FDA Approves Relacorilant With Nab-Paclitaxel for Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, March 25, 2026.
- U.S. Food and Drug Administration (FDA) — Lifyorli (relacorilant) Prescribing Information, March 2026.
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2026.