With a new U.S. green light in certain ovarian cancer patients, Corcept Therapeutics has redeemed its lead asset relacorilant after stumbling at the finish line in a separate indication late last year.
The FDA has given the all-clear to Corcept’s class-first selective glucocorticoid receptor antagonist (SGRA) to treat adults with platinum-resistant ovarian cancer. Patients must have tried one to three prior lines of systemic treatment, at least one of which had to include bevacizumab (Avastin).
The FDA approval covers a regimen of relacorilant, to be sold as Lifyorli, alongside the chemotherapy nab-paclitaxel (Abraxane), according to a March 25 press release. The drug is taken orally the day before, of and after treatment with the regimen’s chemotherapy component, Corcept explained.
Lifyorli is designed to bind to the glucocorticoid receptor, thus enhancing chemotherapy sensitivity by inhibiting cortisol’s suppression of programmed cell death that chemotherapies like Abraxane are meant to cause, the company said.
On launch timing, Corcept is “working to make Lifyorli available as quickly as possible” and expects the drug to be available within one week, a spokesperson told Fierce.
The wholesale acquisition cost for a 28-day cycle of the therapy will land at $37,900, the spokesperson said, clarifying that the company expects Lifyorli to win “broad coverage on most plans, including Medicare and Medicaid.”
The company also has patient assistance options in place for those having trouble accessing the drug, the Corcept representative noted.
Notably, the thumbs-up follows an FDA rejection of relacorilant at the tail end of 2025, albeit for a very different indication.
At that time, Corcept had been aiming for a green light for its antiglucocorticoid in Cushing’s syndrome, a rare disease caused by long-term exposure to too much cortisol. The FDA acknowledged a successful phase 3 study of relacorilant in the indication but stressed the need for “additional evidence of effectiveness” to reach a conclusion, Corcept explained in late December.
The company said it remained committed to the indication and planned to meet with the FDA promptly to work on a potential path forward.
With regards to the new oncology nod, the FDA based its approval on the pivotal Rosella study, which pitted Lifyorli-plus-Abraxane against solo Abraxane in 381 previously-treated ovarian cancer patients.
The study met its dual primary endpoints of progression-free and overall survival, according to the company.
Participants on the Lifyorli regimen experience a 35% reduction in risk of death compared to patients on chemotherapy alone. Median overall survival for the study-drug cohort landed at 16 months, versus 11.9 months for those treated with Abraxane monotherapy.
Corcept noted that its drug appeared well-tolerated and manageable in a pooled analysis of patients from Rosella and Lifyorli’s midstage trial. The medication’s label includes warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids and embryo-fetal toxicity,
“It is a privilege to bring forward a new treatment for patients who historically have had few options,” Joseph Belanoff, M.D., Corcept’s CEO, said in a statement. “We have worked for years to demonstrate the potential of cortisol modulation in oncology. Today’s approval of Lifyorli is an important first step, but there is much more to explore with this new mode of treatment.”
Belanoff’s company is indeed aiming its relacorilant development at multiple potential oncology indications, including endometrial, cervical, pancreatic and prostate cancers.
The FDA’s verdict on Lifyorli has come quite early, with Corcept noting at the top of the year that it had expected an approval decision around the middle of July.
Around that time, Alexander Olawaiye, M.D., a University of Pittsburgh physician and the Rosella trial’s principal investigator, opined that relacorilant was “positioned to become a new standard-of-care treatment for patients with platinum-resistant ovarian cancer.”
Corcept’s stock price was trading up nearly 23% around the middle of Wednesday afternoon.