FDA Approves Relacorilant With Nab-Paclitaxel for Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

This article focuses on the U.S. Food and Drug Administration’s (FDA) approval of relacorilant (Lifyorli™), a first-in-class glucocorticoid receptor antagonist, in combination with nab-paclitaxel for treating adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have undergone one to three prior systemic therapies including bevacizumab. The approval was based on the ROSELLA trial, which demonstrated improved progression-free survival and overall survival with the combination compared to nab-paclitaxel alone. Common adverse reactions occurring in at least 20% of patients included decreased hemoglobin and neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite. The prescribing information includes contraindications and warnings related to corticosteroid use, neutropenia, infections, adrenal insufficiency, and embryo-fetal toxicity.