The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending that the European Commission (EC) approve relacorilant (Lifyorli) combined with nab-paclitaxel (Abraxane) for the treatment of patients with platinum-resistant ovarian cancer, according to a news release from the developer, Corcept Therapeutics.1 The EC is expected to issue a final decision on the marketing authorization application in the fourth quarter of 2026.
What data supported the CHMP’s positive opinion?
The CHMP’s recommendation is based on positive data from two trials: a phase 2 study (NCT03776812) and the pivotal phase 3 ROSELLA trial (NCT05257408). Patients receiving relacorilant plus nab-paclitaxel experienced improved progression-free survival (PFS) and overall survival (OS) compared with patients who received nab-paclitaxel alone. In ROSELLA, relacorilant plus nab-paclitaxel achieved a median PFS of 6.5 months (95% CI, 5.6-7.4) vs 5.5 months (95% CI, 3.9-5.9) with nab-paclitaxel alone (HR, 0.70; 95% CI, 0.54-0.91; P = .0076).2 The median OS was 16.0 months (95% CI, 13.0-18.3) vs 11.9 months (95% CI, 10.0-13.8), respectively (HR, 0.65; 95% CI, 0.51-0.83; 2-sided stratified log-rank P = .0004).3 The safety profile of relacorilant plus nab-paclitaxel in these trials was consistent with the safety profile of nab-paclitaxel monotherapy.
“The CHMP’s positive opinion takes us a big step closer to making the benefits of glucocorticoid receptor antagonism available to patients in the EU. We look forward to the European Commission’s final decision,” stated Joseph K. Belanoff, MD, chief executive officer of Corcept, in the press release.1 “I want to thank the CHMP for conducting such an efficient and timely review. I also want to thank the healthcare providers and patients who participated in relacorilant’s clinical trials. Without them, advancing this fundamentally new approach to treating cancer would not have been possible.”
How does this CHMP opinion build on relacorilant’s regulatory history?
Relacorilant plus nab-paclitaxel was approved by the FDA in March 2026 for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic regimens, including bevacizumab (Avastin).4 Relacorilant is the only selective glucocorticoid receptor modulator approved by the FDA for any indication, according to the developer.
What is the ROSELLA trial design?
ROSELLA enrolled 381 patients with platinum-resistant ovarian cancer at sites in the US, Europe, South Korea, Brazil, Argentina, Canada, and Australia.5 Patients were randomized 1:1 to receive relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The trial was conducted in collaboration with the GOG Foundation, the European Network of Gynaecological Oncological Trial groups, the Asia-Pacific Gynecologic Oncology Trials Group, the Latin American Cooperative Oncology Group, and the Australia New Zealand Gynaecological Oncology Group.
Eligible patients had high-grade serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with platinum-resistant status as confirmed by RECIST v1.1 guidelines and defined progression less than 6 months from completion of platinum-containing therapy. Those enrolled were permitted to receive at least 1 but no more than 3 prior lines of systemic therapy, with at least 1 prior line of platinum therapy and a bevacizumab-containing treatment.
What is relacorilant and how does it work?
Relacorilant works by binding to the glucocorticoid receptor without binding to the body’s other hormone receptors. Cortisol is understood to play a role in tumor growth through several mechanisms; it helps solid tumors resist chemotherapy by inhibiting cellular apoptosis and the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, it promotes tumor growth by activating oncogenic signaling, and it suppresses the body’s immune response, weakening its ability to fight disease.
References
- Corcept announces CHMP opinion recommending EU marketing authorization for Lifyorli® (relacorilant). News release. Corcept Therapeutics Incorporated. September 18, 2026. Accessed September 18, 2026. https://tinyurl.com/27cfey4y
- Olawaiye A, Gladieff L, Gilbert L, et al. ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). J Clin Oncol. 2025;43(suppl 17):LBA5507. doi:10.1200/JCO.2025.43.17_suppl.LBA5507
- Olawaiye AB, Quesada S, Gilbert L, et al. Final overall survival results from the phase 3 ROSELLA trial: relacorilant plus nab-paclitaxel vs nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer. Presented at: 2026 SGO Annual Meeting; April 10-13, 2026; San Juan, Puerto Rico.
- FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. News release. FDA. March 25, 2026. Accessed September 18, 2026. https://tinyurl.com/yrxh4y8w
- Relacorilant in combination with nab-paclitaxel in advanced, platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. ClinicalTrials.gov. Updated April 16, 2025. Accessed September 18, 2026. https://tinyurl.com/52wxjjns
