Ovarian cancer is highly malignant, and platinum-resistant recurrence represents a formidable clinical challenge. Treatment options for patients in later lines are limited, creating an urgent unmet need for novel therapeutic regimens. Recently, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion, recommending the marketing authorisation of relacorilant (brand name: Lifyorli) in the European Union. Key data from the pivotal ROSELLA trial were presented at the ESMO Congress and garnered widespread attention across the gynaecologic oncology community.
On 17 September 2026, CHMP adopted a positive opinion recommending a marketing authorisation for relacorilant (Lifyorli) for use in adult patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. The marketing application was submitted by Corcept Therapeutics Netherlands B.V.
Mechanism of Action and Formulation
Lifyorli is supplied as soft capsules available in two strengths: 25 mg and 100 mg. Its active ingredient, relacorilant, is an antineoplastic and immunomodulating hormone antagonist (ATC code: L02BX05), a selective, reversible glucocorticoid receptor (GR) antagonist.
Activation of the glucocorticoid receptor pathway upregulates anti-apoptotic proteins, enabling tumours to develop resistance to chemotherapy. In human cell-line xenograft models, relacorilant blocks this pathway and enhances tumour cell sensitivity to chemotherapy.
Indication and Clinical Benefit
Full indication: Lifyorli in combination with nab-paclitaxel, for adult patients with platinum-resistant high-grade epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who have received 1 to 3 prior lines of systemic therapy.
Trial findings demonstrated that the relacorilant combination regimen improved both progression-free survival (PFS) and overall survival (OS) versus nab-paclitaxel monotherapy, delivering survival benefits for this poor-prognosis patient population. Phase III ROSELLA trial data were featured as a late-breaking oral presentation at the ESMO Congress and serve as the core evidence supporting this CHMP positive opinion.
Safety Profile
The most common adverse reactions of Lifyorli include anaemia, nausea, diarrhoea, neutropenia, constipation, asthenia, abdominal pain, fatigue and decreased appetite. Close monitoring for relevant haematological and gastrointestinal adverse reactions is required during clinical use.
Administration Requirements and Regulatory Status
✅ Treatment note: The Lifyorli plus nab-paclitaxel regimen must be initiated and continuously supervised by physicians experienced in administering anticancer medicinal products.
A positive CHMP opinion does not equate to final EU marketing authorisation. The European Commission typically issues a final decision within 67 days following the opinion. Upon full approval, the full Summary of Product Characteristics (SmPC) will be published on the EMA website in all official EU languages.
The product was granted orphan medicinal product designation during development. EMA will reassess available data to determine whether the orphan designation should be maintained.
Disclaimer: This news summary is compiled from publicly available official materials of ESMO and EMA for academic information sharing only and does not constitute clinical medical advice. This medicinal product has not yet been approved for marketing in China. Clinical treatment decisions must strictly follow domestic clinical guidelines and the advice of attending physicians.
Managing Editor：Tina