Corcept Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. This acceptance marks a crucial regulatory milestone for the company's oncology pipeline.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026, for the relacorilant application. This provides a definitive timeline for a potential approval decision, which could bring a much-needed new treatment option to patients with this dire disease.
The NDA is supported by positive data from the pivotal Phase 3 ROSELLA and Phase 2 trials, which demonstrated improved progression-free and overall survival for patients treated with relacorilant plus nab-paclitaxel. The drug was well-tolerated, with its benefits conferred without increasing the safety burden or requiring biomarker selection.
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