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  6. FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
  1. Resources for Information | Approved Drugs

FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

On March 25, 2026, the Food and Drug Administration approved relacorilant (Lifyorli, Corcept Therapeutics Inc.), 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 who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.

Full prescribing information for Lifyorli will be posted on Drugs@FDA.

Efficacy and Safety

Efficacy was evaluated in ROSELLA (NCT05257408), a multicenter, open-label, trial in 381 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients were permitted to receive up to three prior lines of systemic therapy and prior bevacizumab was required. The trial excluded patients who required chronic or frequent use of glucocorticoids. Patients were randomized (1:1) to receive relacorilant in combination with nab-paclitaxel or nab-paclitaxel alone.

The major efficacy outcome measures were progression-free survival (PFS) assessed by blinded independent central review according to RECIST version 1.1 and overall survival (OS). Median PFS was 6.5 months (95% CI: 5.6, 7.4) in the relacorilant in combination with nab-paclitaxel arm and 5.5 months (95% CI: 3.9, 5.9) in the nab-paclitaxel arm (Hazard ratio 0.70 [95% CI: 0.54, 0.91]; two-sided p-value 0.0076). Median OS was 16 months (95% CI: 13, 18.3) in the relacorilant in combination with nab-paclitaxel arm and 11.9 months (95% CI: 10, 13.8) in the nab-paclitaxel arm (Hazard ratio 0.65 [95% CI: 0.51, 0.83]; two-sided p-value 0.0004).

The prescribing information includes a contraindication for patients who require 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 (incidence ≥ 20%), including laboratory abnormalities, that occurred in patients treated with relacorilant in combination with nab-paclitaxel were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

Recommended Dosage

The recommended dosage of relacorilant is 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion until disease progression or unacceptable toxicity. The recommended dosage for nab-paclitaxel is 80 mg/m2 administered as an intravenous infusion on Days 1, 8 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

This review used the Assessment Aid, a voluntary submission from the Applicant to facilitate the FDA’s assessment. The FDA approved this application 3.5 months ahead of the FDA goal date.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X: @FDAOncology.

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