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On March 25, 2026, the FDA approved Corcept Therapeutics’ Lifyorli (relacorilant) in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic regimens, with at least one prior bevacizumab-containing regimen. The agency said it approved the application 3.5 months ahead of its goal date.
The approval gives Corcept its first oncology product and establishes relacorilant as the first FDA-approved selective glucocorticoid receptor antagonist. According to Corcept, the decision opens a commercial opportunity that includes about 20,000 women in the United States each year who are candidates to start a new therapy, with at least an equal number in Europe.
The FDA’s decision was based on the ROSELLA trial, an open-label study in 381 patients. Median progression-free survival was 6.5 months with relacorilant plus nab-paclitaxel versus 5.5 months with nab-paclitaxel alone. Median overall survival was 16.0 months versus 11.9 months, respectively.
The prescribing information includes a contraindication for patients who require corticosteroids for a lifesaving indication, along with warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity.
Corcept said complete ROSELLA results will be presented at the Society of Gynecologic Oncology meeting in April and that it has submitted a Marketing Authorisation Application to the EMA.
Sources: FDA press announcement; FDA approval letter; Corcept Therapeutics press release.
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