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
Platinum-resistant ovarian cancer is a form of the disease that no longer responds to platinum-based chemotherapy, leaving few effective options and allowing tumors to keep growing. Lifyorli is a pill that blocks the glucocorticoid receptor, a protein that cancer cells use to blunt the immune system's attack and resist chemotherapy. By blocking that receptor, Lifyorli may make tumors more vulnerable to nab-paclitaxel, potentially slowing cancer growth for people whose disease has stopped responding to standard treatment.
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.
