FDA Approves Lifyorli for Platinum-Resistant Ovarian Cancer, Extending Lives

The U.S. Food and Drug Administration approved relacorilant, marketed as Lifyorli, on March 25, 2026, for women with platinum-resistant ovarian cancer — one of the hardest-to-treat gynecologic cancers. The decision, announced by Corcept Therapeutics, brings a new class of medicine into the clinic: a selective cortisol modulator that blocks tumor cells from exploiting the body's stress hormone.

Approval was based on the Phase 3 ROSELLA trial (NCT05257408), which enrolled 381 patients and compared relacorilant combined with nab-paclitaxel chemotherapy against nab-paclitaxel alone. Women who received the combination lived a median of 16 months, compared with 11.9 months for those on chemotherapy alone — a meaningful gain in a disease where every month matters. The regimen also improved progression-free survival and was generally well tolerated.

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Platinum-resistant ovarian cancer typically emerges after standard platinum-based chemotherapy stops working, and options have been limited for decades. By modulating cortisol receptors on tumor cells, relacorilant helps chemotherapy regain its punch. Corcept said it is working with clinicians and patient advocacy groups to make the drug available quickly through oncology centers in the United States and to pursue regulatory approvals abroad.

Patient groups welcomed the news as a long-awaited advance, noting that ovarian cancer has historically received less research investment than other common cancers. The approval is also a proof point for cortisol modulation as a therapeutic strategy, with Corcept and academic collaborators now testing the approach in additional solid tumors.