FDA Grants Approval to Relacorilant Plus Nab-Paclitaxel for Platinum-Resistant Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer

Key Clinical Summary:

• Design/Population: On March 25, 2026, the US FDA approved relacorilant plus nab-paclitaxel for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1 to 3 prior regimens (including bevacizumab), based on the phase 3 ROSELLA trial (NCT05257408), which randomized 381 patients to combination therapy versus nab-paclitaxel alone.
• Key Outcomes: The combination significantly improved PFS and OS. Common adverse events included cytopenias, fatigue, nausea, and diarrhea, consistent with chemotherapy-based regimens, with additional risks related to glucocorticoid pathway modulation.
• Clinical Relevance: Relacorilant plus nab-paclitaxel provides a new, chemotherapy-based combination with survival benefit in platinum-resistant ovarian cancer, addressing a high unmet need and introducing glucocorticoid receptor antagonism as a novel therapeutic strategy in this setting.

On March 25, 2026, the US Food and Drug Administration (FDA) approved the glucocorticoid receptor antagonist relacorilant in combination with nab-paclitaxel for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic regimens, including at least 1 bevacizumab-containing regimen.

For this approval, efficacy was evaluated in the ROSELLA trial (NCT05257408), a multicenter, open-label, randomized study that enrolled 381 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients requiring chronic or frequent glucocorticoid use were excluded. Patients were randomized 1:1 to receive relacorilant plus nab-paclitaxel or nab-paclitaxel monotherapy.

The primary efficacy end points were progression-free survival (PFS), assessed by blinded independent central review per RECIST v1.1, and overall survival (OS).

At analysis, median PFS was 6.5 months (95% confidence interval [CI], 5.6 to 7.4) in the relacorilant combination arm vs 5.5 months (95% CI, 3.9 to 5.9) with nab-paclitaxel alone (hazard ratio [HR], 0.70; 95% CI, 0.54 to 0.91; P = .0076). Median OS was 16.0 months (95% CI, 13.0 to 18.3) vs 11.9 months (95% CI, 10.0 to 13.8; HR, 0.65; 95% CI, 0.51 to 0.83; P = .0004), respectively.

The most common adverse reactions (≥ 20%) included decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite. The prescribing information includes a contraindication for patients requiring corticosteroids for a life-saving indication and warnings and precautions for neutropenia, severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity.

The recommended dose of relacorilant is 150 mg orally once daily on the day before, the day of, and the day after each nab-paclitaxel infusion, continued until disease progression or unacceptable toxicity. The recommended dose of nab-paclitaxel is 80 mg/m² intravenously on days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Source:

US Food and Drug Administration. FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Accessed March 25, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or