FDA Approves Lifyorli Plus Nab-Paclitaxel for Platinum-Resistant Ovarian Cancer

The U.S. Food and Drug Administration has approved Lifyorli (relacorilant), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic treatment regimens, at least 1 of which included bevacizumab. The approval, granted on March 25, 2026, was based on data from the ROSELLA study, an open-label trial that included 381 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Findings from the ROSELLA study showed treatment with relacorilant plus nab-paclitaxel significantly improved progression-free survival and overall survival compared with nab-paclitaxel alone. Median overall survival was 16.0 months in the combination group and 11.9 months in the monotherapy group, representing a hazard ratio of 0.65. Median progression-free survival was 6.5 months and 5.5 months, respectively, with a hazard ratio of 0.70.

The most common adverse reactions reported with relacorilant plus nab-paclitaxel were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite. The prescribing information includes warnings and precautions related to 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.

The recommended dosage of relacorilant is 150mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion until disease progression or unacceptable toxicity. When given with Lifyorli, the recommended dosage of nab-paclitaxel is 80mg/m2 administered as an intravenous infusion on days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity. This dosage for nab-paclitaxel differs from those for other nab-paclitaxel indications.

Separately, the FDA has granted Breakthrough Therapy designation to sofetabart mipitecan (LY4170156) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received prior bevacizumab and mirvetuximab soravtansine, if eligible. Sofetabart mipitecan is a novel folate receptor alpha antibody-drug conjugate that uses proprietary linker technology and an exatecan payload.

The Breakthrough Therapy designation for sofetabart mipitecan is based on encouraging preliminary results from a Phase 1a/b study, showing responses at all dose levels and across all FRα expression levels, including in patients who progressed on prior mirvetuximab soravtansine. These initial data also indicate a promising tolerability profile with low rates of interstitial lung disease, peripheral neuropathy, and alopecia, and no significant ocular toxicity. Sofetabart mipitecan recently advanced into the Phase 3 FRAmework-01 study, a global trial investigating the treatment as a monotherapy in patients with platinum resistant ovarian cancer.