What's Happening?
Corcept Therapeutics has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant, a treatment for patients with platinum-resistant ovarian cancer.
This submission is based on positive data from Phase 3 ROSELLA and Phase 2 trials, which showed improved progression-free and overall survival in patients receiving relacorilant plus nab-paclitaxel compared to nab-paclitaxel monotherapy. Relacorilant, a selective glucocorticoid receptor antagonist, modulates cortisol activity and has been well-tolerated in trials. The U.S. FDA is also reviewing Corcept's application for relacorilant, with a target action date set for July 11, 2026.
Why It's Important?
The submission of relacorilant for EMA approval represents a significant step in addressing the urgent need for better treatment options for platinum-resistant ovarian cancer, a condition with limited therapeutic alternatives. The potential approval of relacorilant could redefine treatment protocols, offering improved survival outcomes without increasing the safety burden on patients. This development is crucial for the approximately 20,000 women in the U.S. and an equal number in Europe who are candidates for new therapies each year.
What's Next?
Corcept Therapeutics is awaiting the FDA's decision on relacorilant's approval for treating platinum-resistant ovarian cancer, with a PDUFA date set for July 11, 2026. The company continues to focus on cortisol modulation research, exploring relacorilant's application in other serious disorders, including hypercortisolism and prostate cancer. Successful approval could lead to expanded use and further clinical trials to explore additional therapeutic benefits.
Beyond the Headlines
Relacorilant's development highlights the role of cortisol in oncology, where it can inhibit chemotherapy's tumor-killing effects and promote tumor growth. Understanding cortisol's impact on cancer progression could lead to broader applications of glucocorticoid receptor antagonists in cancer treatment.
