FDA Approves Relacorilant Plus Nab-Paclitaxel for Platinum-Resistant Ovarian Cancer
Key Clinical Summary
- The US Food and Drug Administration (FDA) approved relacorilant plus nab-paclitaxel for platinum-resistant ovarian cancer after prior bevacizumab exposure.
- ROSELLA trial showed improved median progression-free survivial (PFS) (6.5 vs 5.5 months; HR 0.70; P = .0076) and overall survival (OS) (16 vs 11.9 months; HR 0.65; P = .0004).
- Common adverse events include hematologic toxicities, fatigue, and gastrointestinal effects; corticosteroid-dependent patients are contraindicated.
Relacorilant has received FDA approval in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The March 25, 2026, decision is based on results from the phase 3 ROSELLA trial, demonstrating statistically significant improvements in PFS and OS compared with chemotherapy alone.
Main News
The approval is supported by data from ROSELLA, a multicenter, open-label trial enrolling 381 patients with platinum-resistant disease. Eligible patients had received 1 to 3 prior systemic regimens, including mandatory prior bevacizumab exposure.
Participants were randomized 1:1 to relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The primary endpoints were PFS assessed by blinded independent central review per RECIST v1.1 and OS.
Median PFS was 6.5 months (95% CI, 5.6-7.4) in the combination arm vs 5.5 months (95% CI, 3.9-5.9) with nab-paclitaxel alone (HR 0.70; 95% CI, 0.54-0.91; P = .0076). Median OS was 16 months (95% CI, 13-18.3) vs 11.9 months (95% CI, 10-13.8), respectively (HR 0.65; 95% CI, 0.51-0.83; P = .0004).
Safety findings highlighted risks associated with glucocorticoid receptor antagonism. The prescribing information includes contraindications for patients requiring corticosteroids for lifesaving indications. Warnings include neutropenia, severe infections, adrenal insufficiency, and embryo-fetal toxicity.
The most common adverse reactions (≥20%) included decreased hemoglobin and neutrophils, fatigue, nausea, diarrhea, thrombocytopenia, rash, and decreased appetite.
Clinical Implications
The observed OS improvement of more than 4 months may be clinically meaningful for heavily pretreated patients. The regimen also provides an option for patients previously exposed to bevacizumab, aligning with real-world treatment sequencing.
However, patient selection is critical. Individuals requiring chronic corticosteroids are excluded due to the drug’s mechanism, and clinicians must monitor for adrenal insufficiency and infection risk. Hematologic toxicity also remains a key management consideration when combining relacorilant with chemotherapy.
For oncology pathways and payer considerations, the statistically significant survival benefit may support adoption, though safety monitoring requirements and patient eligibility constraints could influence utilization strategies.
Conclusion
The FDA approval of relacorilant plus nab-paclitaxel marks a new option for platinum-resistant ovarian cancer, supported by improved survival outcomes in the ROSELLA trial. Ongoing clinical integration will depend on careful patient selection and management of safety risks.
Reference
FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. FDA.gov. Press release. Published on March 25, 2026. Accessed April 8, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
