FDA Alert

FDA Approves Relacorilant (Lifyorli) Plus Nab-Paclitaxel for Platinum-Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Anthony Calabro, MA

Key Highlights

  • Relacorilant plus nab-paclitaxel improved progression-free survival and overall survival vs nab-paclitaxel alone.
  • The FDA approval was based on the phase 3 ROSELLA trial in previously treated patients.
  • Median overall survival was 16 months with the combination vs 11.9 months with monotherapy.
  • Common adverse reactions include decreased hemoglobin, decreased neutrophils, fatigue, and gastrointestinal toxicities.

On March 25, the FDA approved relacorilant (Lifyorli), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Eligible patients must have received 1 to 3 prior systemic treatment regimens, including at least 1 that included bevacizumab.

The approval was based on findings from ROSELLA (NCT05257408), a multicenter, open-label trial enrolling 381 patients with platinum-resistant disease. Patients were randomized (1:1) to receive relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The major efficacy outcome measures were progression-free survival (PFS) and overall survival (OS). Median PFS was 6.5 months (95% CI, 5.6–7.4) with the combination vs 5.5 months (95% CI, 3.9–5.9) with nab-paclitaxel alone (hazard ratio, 0.70; P = .0076). Median OS was 16 months (95% CI, 13–18.3) vs 11.9 months (95% CI, 10–13.8), respectively (hazard ratio, 0.65; P = .0004).

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

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

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