EMA’s CHMP recommends relacorilant plus nab-paclitaxel for platinum-resistant ovarian cancer based on improved progression-free and overall survival.
Written By: Mayuri Vaja, PharmD
Reviewed By: Pharmacally Editorial Team
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Corcept Therapeutics’ relacorilant in combination with nab-paclitaxel for patients with platinum-resistant ovarian cancer, based on Phase 2 and pivotal Phase 3 ROSELLA data showing improved progression-free and overall survival.
CHMP Supports Relacorilant Combination
The CHMP recommendation brings relacorilant closer to European availability for women whose ovarian cancer progresses after platinum-based chemotherapy. The European Commission (EC) will now review the positive opinion and is expected to issue a final decision in the fourth quarter of 2026.
The recommendation is supported by results from the Phase 2 development program and the pivotal ROSELLA Phase 3 trial. Across these studies, relacorilant combined with nab-paclitaxel improved progression-free survival (PFS) and overall survival (OS) compared with nab-paclitaxel alone.
Targeting Cortisol Signaling in Cancer
Relacorilant is a selective glucocorticoid receptor modulator that binds the glucocorticoid receptor without binding the body’s other hormone receptors.
The therapeutic rationale is based on the role of cortisol signaling in cancer. Cortisol can activate glucocorticoid receptors in tumor cells and contribute to resistance to chemotherapy by suppressing apoptosis, the programmed cell death that anticancer treatment seeks to induce. Cortisol also has immunosuppressive effects that can weaken antitumor immune responses.
By blocking glucocorticoid receptor activity, relacorilant is being developed to counter these cortisol-mediated effects and potentially increase the effectiveness of chemotherapy.
Relacorilant is already approved in the United States under the trade name Lifyorli for patients with platinum-resistant ovarian cancer.
ROSELLA Phase 3 Trial
The pivotal ROSELLA trial enrolled 381 patients with platinum-resistant ovarian cancer across the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia.
Patients were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The trial was conducted through collaboration with the GOG Foundation and several international gynecologic oncology trial networks.
The combination demonstrated improvements in both PFS and OS compared with nab-paclitaxel monotherapy. The safety profile of relacorilant plus nab-paclitaxel remained consistent with that of nab-paclitaxel alone in the reported studies.
These findings are clinically relevant in platinum-resistant ovarian cancer, where treatment options remain limited and disease progression can occur within six months of starting platinum-based chemotherapy.
European Regulatory Pathway
The CHMP’s positive opinion represents the key scientific review milestone before a potential European authorization. The EC will make the final regulatory decision following its review of the CHMP recommendation.
Joseph K. Belanoff, M.D., Corcept’s chief executive officer, said the opinion moves relacorilant closer to providing glucocorticoid receptor antagonism as a treatment approach for patients in the European Union.
Next Milestone
Corcept expects the European Commission to issue its decision in the fourth quarter of 2026. If the EC grants authorization, relacorilant combined with nab-paclitaxel would move into the European commercial pathway for platinum-resistant ovarian cancer, extending the development of glucocorticoid receptor antagonism beyond its existing U.S. use.
Reference
Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli® (Relacorilant), Corcept Therapeutics, 18 September 2026
About the Writer
Mayuri Vaja (Linkedin) is a Pharm.D professional with a strong interest in clinical research, pharmacovigilance, and medical writing, supported by certifications in pharmacovigilance and academic projects exploring AI in healthcare and drug safety.
With a growing focus on evidence-based healthcare and scientific communication, she is developing expertise in clinical research and translating healthcare evidence into clear, meaningful content.
As a Pharmacally healthcare writer, Mayuri is committed to creating accurate, research-driven, and clinically relevant healthcare content while continuously strengthening her professional skills.