What's Happening?
Corcept Therapeutics has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant, aimed at treating patients with platinum-resistant ovarian cancer.
This submission is supported by positive data from Phase 3 ROSELLA and Phase 2 trials, which demonstrated improved progression-free and overall survival rates for patients receiving relacorilant combined with nab-paclitaxel, compared to those receiving nab-paclitaxel alone. The treatment was well-tolerated, with adverse events comparable to the monotherapy group. The U.S. Food and Drug Administration (FDA) is also reviewing Corcept's application for relacorilant in the United States, with a Prescription Drug User Fee Act (PDUFA) target action date set for July 11, 2026.
Why It's Important?
The submission of relacorilant to the EMA represents a significant step in addressing the urgent need for better treatment options for platinum-resistant ovarian cancer, a condition with limited therapeutic alternatives and a median overall survival of approximately 12 months post-recurrence. If approved, relacorilant could redefine treatment protocols for this aggressive cancer type, potentially improving survival rates and quality of life for thousands of women annually. The drug's development also highlights the role of cortisol modulation in oncology, offering insights into new therapeutic pathways for other serious disorders.
What's Next?
The FDA's review process for relacorilant is ongoing, with a decision expected by mid-2026. Should the EMA approve the application, Corcept Therapeutics will be positioned to expand its market reach in Europe, potentially influencing treatment standards across the continent. The company is also exploring relacorilant's application in other disorders, including hypercortisolism and prostate cancer, which could further broaden its impact in the medical field.
Beyond the Headlines
Relacorilant's development underscores the importance of innovative approaches in cancer treatment, particularly in modulating hormonal pathways that contribute to tumor growth and chemotherapy resistance. This advancement may prompt further research into cortisol's role in oncology, potentially leading to new strategies for combating various cancers and enhancing immune response.
