The FDA has approved relacorilant (Lifyorli, Corcept Therapeutics) in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, including at least one with bevacizumab.

Relacorilant is a first-in-class selective glucocorticoid receptor antagonist for platinum-resistant ovarian cancer. It enhances chemotherapy sensitivity by competitively binding glucocorticoid receptors and inhibiting cortisol suppression of apoptosis.

Corcept is also developing the drug for endometrial, cervical, pancreatic, and prostate cancers, the company said in a press release. 

Approval was based on the open-label ROSELLA trial in 381 patients with platinum-resistant disease who were randomly assigned evenly to either relacorilant with nab-paclitaxel or nab-paclitaxel alone. 

Median progression-free survival was 6.5 months in the relacorilant combination arm vs 5.5 months with nab-paclitaxel alone (HR, 0.70; P = .0076). Median overall survival was 16 months with the combination vs 11.9 months (HR, 0.65; P = .0004).

“The results position the combination of relacorilant and nab-paclitaxel as a potential new standard treatment for patients with platinum-resistant ovarian cancer,” the investigators concluded in a paper published last year in The Lancet. 

Relacorilant is contraindicated for patients taking systemic glucocorticoids for lifesaving indications. Labeling also warns of neutropenia with severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity.

The most common adverse events in ROSELLA, occurring in more than 20% of relacorilant/nab-paclitaxel patients, were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and appetite loss. 

Relacorilant is administered 150 mg orally once on the day before, the day of, and the day after nab-paclitaxel infusions, which are delivered on days 1, 8, and 15 of 28-day cycles.

Complete blood counts should be monitored before each weekly administration, with relacorilant dosing delayed, reduced, or discontinued based on the degree of neutropenia.

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com