FDA Approves Relacorilant Combo for Platinum-Resistant Ovarian Cancer
The Food and Drug Administration approved a new treatment regimen on March 25, 2026, for adults battling platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancers. The combination therapy, featuring relacorilant (Lifyorli, Corcept Therapeutics) alongside nab-paclitaxel (Abraxane, Bristol Myers Squibb), offers a new option for patients whose disease has progressed after prior treatments, including bevacizumab.
This approval marks the first selective glucocorticoid receptor antagonist therapy available for this challenging cancer type. The decision is based on data from the phase 3 ROSELLA trial, which demonstrated significant improvements in both progression-free survival (PFS) and overall survival (OS) compared to nab-paclitaxel alone.
Understanding Platinum Resistance and the Demand for New Options
Ovarian cancer, while often initially responsive to platinum-based chemotherapy, frequently develops resistance to these drugs. This “platinum resistance” represents a major obstacle in treatment, leading to poorer outcomes. Patients with platinum-resistant disease have limited therapeutic options, highlighting the critical need for innovative approaches like the relacorilant combination.
The ROSELLA trial enrolled 381 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancers who had previously received bevacizumab. Participants were randomly assigned to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel monotherapy. The trial’s primary endpoints were PFS and OS and the results showed a compelling benefit with the addition of relacorilant.
Key Findings from the ROSELLA Trial
The study revealed a 30% improvement in PFS for those receiving relacorilant plus nab-paclitaxel, with a median PFS of 6.5 months compared to 5.5 months for nab-paclitaxel alone (HR = 0.7; 95% CI, 0.54-0.91). Even more significantly, the combination therapy demonstrated a 35% improvement in OS, with a median OS of 16 months versus 11.9 months in the nab-paclitaxel-only group (HR = 0.65; 95% CI, 0.51-0.83).
Alexander B. Olawaiye, MD, director of gynecologic cancer research at Magee-Women’s Hospital of University of Pittsburgh and the primary investigator of the trial, expressed his enthusiasm for the findings, stating, “It was a feeling of innate joy that I could be part of something that would build a difference to so many women.”
How Relacorilant Works: Targeting the Glucocorticoid Receptor
Relacorilant is a selective glucocorticoid receptor antagonist. Glucocorticoid receptors are proteins found inside cells that, when activated, can promote cancer growth and resistance to chemotherapy. By blocking these receptors, relacorilant aims to overcome these mechanisms and enhance the effectiveness of chemotherapy. This approach represents a novel strategy in ovarian cancer treatment, moving beyond traditional chemotherapy agents.
Safety Profile and Adverse Reactions
As with any cancer treatment, relacorilant is associated with potential side effects. The most commonly reported adverse reactions in the combination group included anemia, neutropenia (low white blood cell count), fatigue, nausea, diarrhea, thrombocytopenia (low platelet count), rash, and decreased appetite. The FDA provides detailed information on these and other potential side effects in the prescribing information for Lifyorli.
Dosage and Administration
The recommended dosage of relacorilant is 150 mg administered orally on the day before, the day of, and the day after each nab-paclitaxel infusion. Treatment should continue until disease progression or unacceptable toxicity occurs. Nab-paclitaxel is administered intravenously at a dose of 80 mg/m2 on days 1, 8, and 15 of each 28-day cycle, also continuing until disease progression or unacceptable toxicity.
Contextualizing the Impact: Ovarian Cancer Statistics and Challenges
Ovarian cancer is the fifth leading cause of cancer death among women in the United States, according to the Centers for Disease Control and Prevention. Approximately 22,530 women will be diagnosed with ovarian cancer in 2026, and around 17,440 will die from the disease. The majority of cases are diagnosed at an advanced stage, when the cancer has already spread, making treatment more challenging. This new approval offers a much-needed advancement for patients facing this challenging diagnosis.
What’s Next: Ongoing Research and Future Directions
The approval of relacorilant plus nab-paclitaxel is a significant step forward, but research continues. Further studies are planned to investigate the potential of relacorilant in combination with other chemotherapy regimens and to identify biomarkers that may predict which patients are most likely to benefit from this treatment. Researchers are also exploring the role of the glucocorticoid receptor in other cancer types, potentially expanding the application of this novel therapeutic approach. The FDA will continue to monitor the safety and effectiveness of relacorilant through post-market surveillance.
The National Cancer Institute (NCI) provides comprehensive information on ovarian cancer, including ongoing clinical trials and research initiatives. Patients and healthcare providers can find valuable resources on the NCI website to stay informed about the latest advancements in ovarian cancer treatment.