The US Food and Drug Administration (FDA) has approved Lifyorli (relacorilant) in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. 

It is approved in patients who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.  

Lifyorli is the first FDA-approved selective glucocorticoid receptor antagonist (SGRA). It competitively binds to the glucocorticoid receptor (GR), where it enhances chemotherapy sensitivity by inhibiting cortisol’s suppression of apoptosis. 

Approval was based on the positive outcomes of Lifyorli’s pivotal ROSELLA trial, in which patients treated with Lifyorli in addition to nab-paclitaxel experienced a 35% reduction in the risk of death compared to patients treated with nab-paclitaxel alone, with a median overall survival (OS) of 16.0 months, compared to 11.9 months.  

Patients who received Lifyorli in addition to nab-paclitaxel also experienced a 30% reduction in the risk of disease progression, as assessed by blinded independent central review (PFS-BICR), compared to patients treated with nab-paclitaxel alone. 

“The FDA’s approval of Lifyorli in combination with nab-paclitaxel is welcome news to all of us in the ovarian cancer community,” said Sarah DeFeo, Chief Program Officer at Ovarian Cancer Research Alliance (OCRA). “We are grateful to everyone who participated in the clinical trials, their families and the physicians who helped advance this urgently needed treatment option for patients with platinum-resistant ovarian cancer.” 

“It is a privilege to bring forward a new treatment for patients who historically have had few options,” added Dr Joseph Belanoff, Corcept’s Chief Executive Officer. “We have worked for years to demonstrate the potential of cortisol modulation in oncology. Today’s approval of Lifyorli is an important first step, but there is much more to explore with this new mode of treatment.”