FDA Approves LIFYORLI (relacorilant) with nab‑paclitaxel After ROSELLA Trial Shows Survival Gain in Platinum‑Resistant Ovarian Cancer

A phase 3 trial has produced one of the clearest survival gains reported in patients with platinum‑resistant ovarian cancer, and the U.S. Food and Drug Administration has approved the new drug regimen based on those results.

The ROSELLA study (GOG‑3073/ENGOT‑ov72) found that adding the selective glucocorticoid receptor antagonist relacorilant to weekly nab‑paclitaxel extended median overall survival to 16.0 months, compared with 11.9 months for nab‑paclitaxel alone. The regimen, marketed by Corcept Therapeutics as LIFYORLI, received FDA approval on March 25, 2026 for adults with platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic regimens, at least one of which included bevacizumab.

How the trial was done

• Population: 381 adults with platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal cancer enrolled from Jan. 5, 2023, to April 8, 2024, at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia.
• Design: Randomized, open‑label phase 3 with blinded independent central review of tumor responses and progression.
• Treatment arms: Combination arm received nab‑paclitaxel 80 mg/m2 on days 1, 8 and 15 of a 28‑day cycle plus relacorilant 150 mg taken orally the day before, the day of and the day after each infusion. Control arm received nab‑paclitaxel 100 mg/m2 on the same schedule.
• Endpoints: Co‑primary endpoints were progression‑free survival (PFS) and overall survival (OS).

Key results

• Progression‑free survival: Median PFS was 6.5 months with relacorilant plus nab‑paclitaxel versus 5.5 months with nab‑paclitaxel alone (hazard ratio 0.70; p = 0.0076).
• Overall survival: In an interim analysis with a data cutoff of Feb. 24, 2025, median OS was 16.0 months for the combination and 11.5 months for chemotherapy alone (hazard ratio 0.69; nominal p = 0.012). A later data cut used in the FDA review reported median OS 16.0 vs 11.9 months with a hazard ratio of 0.65 (reported p = 0.0004).

Why the drug may work

Relacorilant is a selective glucocorticoid receptor antagonist (SGRA). Preclinical and early‑phase clinical evidence suggested that cortisol signaling can make tumor cells less susceptible to chemotherapy‑induced cell death. By blocking the glucocorticoid receptor around the time of taxane treatment, relacorilant is intended to "sensitize" tumors to nab‑paclitaxel.

Notably, ROSELLA did not require biomarker selection; benefits were observed in an unselected platinum‑resistant population. That could simplify clinical implementation, though clinicians and payers are likely to scrutinize subgroup data (for example, prior PARP‑inhibitor exposure) as they evaluate who stands to benefit most.

Safety and practical considerations

The safety profile reflected expected chemotherapy‑related toxicities. The combination was associated with neutropenia, anemia, fatigue and nausea. Serious adverse reactions occurred in about 35% of patients receiving relacorilant plus nab‑paclitaxel. Approximately 38% of patients began granulocyte colony‑stimulating factor (G‑CSF) in the first one or two cycles to manage low white blood cell counts.

The prescribing information for LIFYORLI includes warnings about neutropenia and severe infections, adrenal insufficiency, interactions with systemic glucocorticoids and embryo‑fetal toxicity. The label advises avoiding relacorilant in patients who require systemic glucocorticoids for life‑saving indications.

Regulatory and access issues

Corcept funded ROSELLA and has arranged U.S. distribution, including a national specialty pharmacy partnership with Onco360. As the regimen reaches clinics, insurance coverage decisions, prior‑authorization policies and patient out‑of‑pocket costs will influence uptake.

Limitations and next steps

ROSELLA was open‑label, which can introduce bias in some outcomes, though overall survival is less susceptible than PFS. Post‑study therapies and longer follow‑up could affect survival estimates; additional data will help clarify durability of benefit and effects in clinically important subgroups.

For oncologists and patients facing platinum‑resistant disease — a setting where effective options have been limited and median survival often ranges from about 10 to 16 months — the ROSELLA results offer a treatment that both delays progression and extends life by several months on average.

Corcept Chief Executive Joseph Belanoff said in the company announcement, "It is a privilege to bring forward a new treatment for patients who historically have had few options." Patient advocacy groups also welcomed the approval; Sarah DeFeo, chief program officer at the Ovarian Cancer Research Alliance, called the decision "welcome news to all of us in the ovarian cancer community."