FDA approves relacorilant for resistant ovarian cancer

Silver Spring, Md. — The U.S. Food and Drug Administration has approved relacorilant (Lifyorli) in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after prior treatment, according to the FDA, The ASCO Post, Las Vegas Sun, CancerNetwork, TradingView, and Stocktwits. Each of the bullet points immediately below have been confirmed by at least four of the six respected sources we curated on this story.

Core Facts

• The FDA approved relacorilant (brand name Lifyorli) in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, including at least one bevacizumab-containing regimen.
• The approval is supported by results from ROSELLA (NCT05257408), a multicenter, open-label trial that enrolled 381 patients and compared relacorilant plus nab-paclitaxel with nab-paclitaxel alone.
• In ROSELLA, the combination therapy demonstrated longer overall survival and progression-free survival than nab-paclitaxel alone, including a median overall survival of 16 months vs 11.9 months and a median progression-free survival of 6.5 months vs 5.5 months.
• The recommended relacorilant dose is 150 mg taken orally 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 a 28-day cycle.
• The prescribing information includes a contraindication for patients who require corticosteroids for a lifesaving indication, along with warnings and precautions that include neutropenia, serious infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity.
• Common adverse reactions observed with the combination include decreased hemoglobin and neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

Additional Details Reported

Relacorilant is a selective glucocorticoid receptor antagonist. In FDA materials and multiple reports on the approval, the treatment is described as an oral regimen taken around scheduled nab-paclitaxel infusions.

The FDA’s approval notice stated the agency approved the application ahead of its goal date.

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