Relacorilant + nab-paclitaxel

Note: APPROVED EARLY — brand name Lifyorli (relacorilant), approved 2026-03-25, roughly 3.5 months AHEAD of the 2026-07-11 PDUFA target action date. That early action is exactly why the auto-matcher reported "no FDA approval found in window": it searched on/after the PDUFA date, but the FDA acted well before it. Approved indication: 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 regimens, at least one containing bevacizumab. Lifyorli is described by the company as the first FDA-approved selective glucocorticoid receptor antagonist (SGRA). Basis: pivotal Phase 3 ROSELLA (n=381), which met dual primary endpoints — median OS 16.0 vs 11.9 months (HR 0.65, p=0.0004) and a 30% reduction in progression risk (HR 0.70, p=0.008, PFS-BICR). FDA acted 2026-03-25 (target was 2026-07-11). Source: https://www.sec.gov/Archives/edgar/data/1088856/000119312526123543/d123475d8k.htm