FDA Approves Lifyorli for Platinum-Resistant Ovarian Cancer, a First for Cortisol Modulation in Oncology

The US FDA on March 25, 2026, approved Lifyorli (relacorilant) in combination with nab-paclitaxel for the treatment of adults 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. The Lifyorli relacorilant FDA approval, granted to Corcept Therapeutics, makes relacorilant the first selective glucocorticoid receptor antagonist to receive FDA approval and the first cortisol-modulating agent approved for use in oncology. The Corcept Therapeutics FDA approval also represents the company's second marketed product, following Korlym (mifepristone) for Cushing's syndrome in 2012. No biomarker selection is required for Lifyorli, distinguishing it from other recently approved agents in this setting.

Lifyorli is an oral medication administered the day before, the day of, and the day after each nab-paclitaxel infusion. The approved indication specifies adults with platinum-resistant disease who have received between one and three prior systemic regimens, with prior bevacizumab exposure required. The prescribing information includes warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity. Lifyorli is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes, such as immunosuppression following organ transplantation.

The approval was based on results from the ROSELLA trial, a Phase III randomized study that enrolled 381 patients across sites in the United States, Europe, South Korea, Brazil, Argentina, Canada, and Australia. Patients were randomized 1:1 to receive relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The trial met its dual primary endpoints of progression-free survival and overall survival. Patients receiving the relacorilant combination experienced a 35% reduction in the risk of death compared to nab-paclitaxel monotherapy (hazard ratio: 0.65; p=0.0004), with median overall survival of 16.0 months versus 11.9 months. The combination also produced a 30% reduction in the risk of disease progression as assessed by blinded independent central review (hazard ratio: 0.70; p=0.008). Safety was assessed in a pooled analysis from ROSELLA and a Phase II trial. The most common adverse reactions occurring in more than 20% of patients included decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite. Serious adverse reactions occurred in 35% of patients, and fatal adverse reactions were reported in 2.1%. Data from ROSELLA were first presented at ASCO 2025 with simultaneous publication in The Lancet, the company said.

The approval of Lifyorli for ovarian cancer arrives in a setting where treatment options have historically been limited and outcomes remain poor. Ovarian cancer is the fifth most common cause of cancer death in women, and patients whose disease recurs within six months of platinum-based therapy face a median overall survival that has, until recently, rarely exceeded 12 months with standard chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with the company estimating at least an equal number in Europe. Relacorilant's mechanism, blocking the glucocorticoid receptor to counteract cortisol-mediated suppression of chemotherapy-induced apoptosis, represents a mechanistic approach distinct from other approved therapies. The selective glucocorticoid receptor antagonist does not interact with other steroid receptors, which differentiates it pharmacologically from mifepristone. Corcept is also developing relacorilant in endometrial, cervical, pancreatic, and prostate cancers, and has submitted a Marketing Authorisation Application to the European Medicines Agency for the platinum-resistant ovarian cancer indication. Relacorilant has been designated an orphan drug by the European Commission for ovarian cancer treatment.

Lifyorli joins a competitive landscape that includes mirvetuximab soravtansine (Elahere), an FRα-directed antibody-drug conjugate approved for biomarker-selected patients, and pembrolizumab (Keytruda), approved in February 2026 in combination with paclitaxel for PD-L1-positive disease. Unlike both of those agents, Lifyorli does not require companion diagnostic testing, potentially broadening its eligible patient population. Several investigational agents are also in late-stage development for this indication, including antibody-drug conjugates such as raludotatug deruxtecan (Phase III), WEE1 inhibitors such as azenosertib (Phase III), and bispecific antibodies such as navicixizumab (Phase III).

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