Lifyorli Approved for Platinum-Resistant Ovarian Cancer
On March 25, 2026, the US Food and Drug Administration (FDA) approved Corcept Therapeutics’ Lifyorli™ (relacorilant) in combination with nab‑paclitaxel for the treatment of adult patients with platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. An oral selective glucocorticoid receptor (GR) antagonist designed to block cortisol‑mediated chemotherapy resistance pathways, Lifyorli is administered with nab-paclitaxel and is thought to make ovarian cancer cells more sensitive to the taxane therapy. This is a first-in-class oral selective GR antagonist for oncology use. The recommended dose is 150mg orally administered on the day before, the day of, and the day after each nab‑paclitaxel infusion. Nab‑paclitaxel is administered at 80mg/m² intravenously (IV) on days one, eight, and 15 of each 28‑day cycle. Treatment is continued until disease progression or unacceptable toxicity. The FDA approved this about two and a half months ahead of its July goal date. Here is the prescribing information.
At a Glance
- Brand Drug: Lifyorli™ (relacorilant)
- Manufacturer: Corcept Therapeutics
- Date Approved: March 25, 2026
- Indication: In combination with nab‑paclitaxel for adult patients with platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab
- Dosage Forms Available: 25mg and 100mg capsules
- Launch Date: Expected soon.
- Estimated Annual Cost: Not yet announced.
- FDA Designation: N/A
- Platinum‑resistant ovarian cancer recurs or progresses within six months of completing platinum‑based chemotherapy. This form of disease is associated with poor prognosis and limited treatment options, as response rates to subsequent therapies are generally low and remissions are short‑lived.
- Corcept estimates that approximately 20,000 women are treated for ovarian cancer that relapses within six months of platinum‑based chemotherapy annually in the US.
- In the pivotal trial, Lifyorli plus nab‑paclitaxel improved both progression‑free survival (PFS) and overall survival (OS) compared with nab‑paclitaxel alone, with median PFS of 6.5 months versus 5.5 months, and median OS was 16.0 months versus 11.9 months.
- Lifyorli is contraindicated in patients who require corticosteroids for life‑saving indications. Warnings include neutropenia and serious infections, adrenal insufficiency, worsening of conditions treated with glucocorticoids, and embryo‑fetal toxicity.
- Common adverse reactions included hematologic abnormalities, fatigue, gastrointestinal events, rash, and decreased appetite.
- Relacorilant previously received a Complete Response Letter (CRL) in December 2025 for the treatment of high blood pressure due to hypercortisolism, with the FDA citing the need for additional evidence of effectiveness.
- Lifyorli is also being studied in other tumor types, including cervical, endometrial, pancreatic, and prostate cancers, which could support additional indications in the future.