Overview
- Relacorilant (Lifyorli) won FDA approval Wednesday for use with nab-paclitaxel in adults whose platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer progressed after one to three prior regimens that included bevacizumab.
- In the phase 3 ROSELLA trial of 381 patients, the combination produced a median progression-free survival of 6.5 months vs 5.5 months and a median overall survival of 16.0 months vs 11.9 months, with hazard ratios of 0.70 for PFS and 0.65 for OS.
- Relacorilant blocks the glucocorticoid receptor, which prevents cortisol from dampening chemotherapy-triggered cell death, a new way to help chemo work in a setting with few effective options.
- The label bars use in patients who need systemic steroids for lifesaving reasons and warns about low white blood cells with serious infections, adrenal insufficiency, flares of steroid-treated conditions, and embryo–fetal harm, with common side effects like anemia, neutropenia, fatigue, nausea, and diarrhea.
- Shares of Corcept rose about 40% after the decision, and investigators plan to present full ROSELLA results at the Society of Gynecologic Oncology meeting in April.