Corcept Therapeutics' NDA for relacorilant as a treatment for platinum-resistant ovarian cancer has been accepted by the FDA.
Relacorilant showed positive results in Phase 3 and Phase 2 trials, improving patient outcomes without increasing safety concerns.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026, for Corcept's NDA.
Positive Trial Results
Relacorilant plus nab-paclitaxel improved progression-free and overall survival in patients with platinum-resistant ovarian cancer.
Safety Profile
Relacorilant was well-tolerated with no additional safety burden on patients compared to monotherapy.
Potential Treatment Option
Corcept's NDA acceptance brings hope for a new treatment option in a dire disease like platinum-resistant ovarian cancer.
Mechanism of Action
Relacorilant, a selective GR antagonist, modulates cortisol activity without affecting other hormone receptors.
- Relacorilant offers a promising approach to redefine the treatment landscape for platinum-resistant ovarian cancer.
- Patients may benefit from improved survival and progression-free outcomes, potentially enhancing quality of life.
Corcept's acceptance of the NDA for relacorilant marks a significant step towards addressing the unmet medical needs of patients with platinum-resistant ovarian cancer. The positive trial results and favorable safety profile highlight the potential impact of this new treatment option.