for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (combination with nab-paclitaxel; ≥1 prior regimen incl. bevacizumab)
NDA· Standard Review
FDA approved Lifyorli (relacorilant) plus nab-paclitaxel on March 25, 2026 — more than three months ahead of the Jul 10 2026 PDUFA target. First FDA-approved selective glucocorticoid receptor antagonist (SGRA). Indicated for adults with platinum-resistant ovarian / fallopian tube / primary peritoneal cancer who have received 1–3 prior systemic regimens, at least one including bevacizumab. Based on positive Phase 3 ROSELLA OS+PFS data.
About
Ovarian cancer is an aggressive disease that often spreads beyond the reproductive organs and becomes resistant to platinum-based chemotherapy. Lifyorli (relacorilant) blocks the glucocorticoid receptor, a biological switch that cancer cells hijack to grow and evade treatment. By disrupting this survival pathway alongside chemotherapy, Lifyorli may help slow disease progression in patients who’ve run out of platinum-based options.
The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of Relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.
