Oncologists and gynecologic oncology clinicians treating adults with platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic regimens including bevacizumab are the primary population affected by this approval ^[2][4]. The FDA approval supports use of relacorilant 150 mg orally on the day before, the day of, and the day after each nab‑paclitaxel infusion in combination with nab‑paclitaxel (recommended nab‑paclitaxel dosing when combined: 80 mg/m2 on Days 1, 8, and 15 of a 28‑day cycle) based on ROSELLA, which showed improved PFS (HR 0.70; 95% CI 0.54-0.91) and OS (HR 0.65; 95% CI 0.51-0.83) versus nab‑paclitaxel alone ^[4][2]. How clinicians should balance the regimen’s survival benefit against the high incidence of neutropenia and the label‑recommended monitoring, G‑CSF use, and dose modifications remains a key practical question?

Q1 What is relacorilant (LIFYORLI) approved for?

LIFYORLI (relacorilant) is approved 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. This indication and the supporting clinical data derive from the ROSELLA randomized phase 3 trial cited in the prescribing information.

Q2 How does relacorilant work?

Relacorilant is a selective, reversible glucocorticoid receptor antagonist. In preclinical models, GR antagonism with relacorilant enhanced apoptosis and antitumor activity when administered with paclitaxel; the label describes relacorilant as blocking cortisol‑mediated GR signalling and inhibiting cortisol‑induced reduction of pro‑inflammatory cytokines in stimulated immune cells, which may increase tumour sensitivity to chemotherapy.

Q3 What is the recommended dose of LIFYORLI?

The recommended LIFYORLI dosage is 150 mg orally once on the day before, the day of, and the day after each nab‑paclitaxel infusion. When administered in combination with LIFYORLI, the recommended nab‑paclitaxel dose is 80 mg/m2 IV on Days 1, 8, and 15 of each 28‑day cycle. Dosing modifications for adverse reactions and detailed administration instructions are included in the full prescribing information. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the most common side effects observed with relacorilant plus nab‑paclitaxel?

In ROSELLA, the most common adverse reactions (incidence >20%) with relacorilant in combination with nab‑paclitaxel included decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite. Decreased neutrophil count was reported in 74% of patients treated with the combination (30% Grade 3; 15% Grade 4) and febrile neutropenia occurred in 3.7% of patients; infections were temporally associated with neutropenia in 16% of patients. The label also warns of adrenal insufficiency and contraindicates LIFYORLI in patients receiving systemic glucocorticoids for lifesaving indications. Clinicians should consult current prescribing information for complete dosing guidance.