Corcept's Lifyorli Wins FDA Approval for Ovarian Cancer Four Months Early — A Major Comeback
By FieldPulse Editorial · March 25, 2026
Tags: FDA, Oncology, Clinical Trials
The FDA approved Corcept Therapeutics' Lifyorli for platinum-resistant ovarian cancer, clearing it four months ahead of its target date. The approval marks a significant turnaround for a drug that previously faced an FDA rejection.
Corcept Therapeutics scored a landmark FDA approval on March 25 for Lifyorli (relacorilant) in platinum-resistant ovarian cancer — and the circumstances surrounding the clearance make it one of the more compelling regulatory stories of the year.
Lifyorli is the first FDA-approved selective glucocorticoid receptor antagonist (SGRA), a novel mechanism that sets it apart from the established landscape of ovarian cancer treatments.
The drug is approved in combination with nab-paclitaxel, a chemotherapy agent already widely used in this patient population.
The approval rests on data from the ROSELLA trial, a 381-patient study that demonstrated a 35 percent reduction in the risk of death for patients receiving Lifyorli plus nab-paclitaxel compared to nab-paclitaxel alone.
Median overall survival in the combination arm was 16.0 months versus 11.9 months in the control group.
The combination also reduced the risk of disease progression by 30 percent.
For a disease setting as difficult as platinum-resistant ovarian cancer — where treatment options are limited and outcomes are poor — those are meaningful numbers.
The FDA cleared Lifyorli approximately four months ahead of its Prescription Drug User Fee Act (PDUFA) target date, a signal of regulatory confidence in the submission package.
What makes this approval particularly striking is the company's recent history.
Corcept had previously received an FDA rejection for relacorilant in a different indication, a setback that cast a shadow over the molecule's future.
The ovarian cancer approval is a full rehabilitation of that narrative — and the market agreed, sending Corcept's stock up roughly 20 percent on the news.
For oncology reps, Lifyorli enters a competitive but clinically unmet space.
Platinum-resistant ovarian cancer patients have historically cycled through chemotherapy regimens with limited benefit.
The SGRA mechanism is new to oncology, which means medical education will be a significant part of any launch conversati.