What's Happening?
Corcept Therapeutics has announced that the FDA has accepted its New Drug Application (NDA) for relacorilant, a treatment for patients with platinum-resistant ovarian cancer. The NDA is based on positive data from Phase 3 ROSELLA and Phase 2 trials, which showed improved progression-free and overall survival for patients receiving relacorilant plus nab-paclitaxel compared to nab-paclitaxel monotherapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026, for the application.
Why It's Important?
The acceptance of Corcept's NDA is a critical step towards providing a new treatment option for patients with platinum-resistant ovarian cancer, a condition with limited therapeutic alternatives. Relacorilant's potential approval could redefine treatment strategies for this aggressive cancer, offering hope for improved survival rates. The drug's ability to modulate cortisol activity without increasing safety burdens is particularly promising for enhancing patient outcomes.
What's Next?
The FDA will review the NDA, with a decision expected by the PDUFA date in July 2026. If approved, relacorilant could become a new standard of care for platinum-resistant ovarian cancer, potentially improving survival rates and quality of life for affected patients.
