Dr Olawaiye on the FDA Approval of Relacorilant Plus Nab-Paclitaxel in PROC

“[This approval] is clinically very impactful because [ROSELLA] used relacorilant and nab-paclitaxel in a non–biomarker-selected population. There was no testing required for patients to participate in the trial if they met all the other inclusion criteria.”

Alexander B. Olawaiye, MD, a professor and the vice chair for Diversity, Equity, and Inclusion in the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Pittsburgh, director of Gynecologic Cancer Research at Magee-Womens Hospital of the University of Pittsburgh School of Medicine, and principal investigator of the Gynecologic Oncology Group Foundation for the University of Pittsburgh Cancer Institute, discusses the significance of the FDA approval of relacorilant (Lifyorli) plus nab-paclitaxel (Abraxane) in platinum-resistant ovarian cancer.

In March 2026, the FDA approved relacorilant in combination with nab-paclitaxel for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received 1 to 3 systemic treatment regimens, at least 1 of which included bevacizumab (Avastin). The approval was supported by data from the phase 3 ROSELLA trial (NCT05257408).

ROSELLA enrolled patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received a maximum of 3 prior lines of systemic therapy, including prior bevacizumab. In this study, patients who received the combination (n = 188) experienced significant improvement in progression-free survival (HR, 0.70; 95% CI, 0.54-0.91; 2-sided P = .0076) and overall survival (HR, 0.65; 95% CI, 0.51-0.83; 2-sided P = .0004) outcomes vs nab-paclitaxel alone (n = 193).

Of note, the prescribing information for relacorilant contains a contraindication for patients who require corticosteroids for a life-saving indication. It also includes warnings and precautions for neutropenia, severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity.

Olawaiye noted that the approval is clinically meaningful because ROSELLA evaluated the combination of relacorilant nab-paclitaxel in a non–biomarker-selected patient population. Thus, the combination is now available for a wider portion of patients compared with other approvals in the space that have biomarker constraints.