USFDA Approves Corcept Therapeutics' Ovarian Cancer Drug Lifyorli
Bengaluru: Corcept Therapeutics shares jumped more than 23% to a near two-month high on Wednesday after the U.S. health regulator approved the company's lead drug for treating an aggressive form of ovarian cancer that no longer responds to standard treatment.
The U.S. Food and Drug Administration approved relacorilant, brand name Lifyorli, for use in combination with the chemotherapy drug nab-paclitaxel.
The therapy is cleared for adults with platinum-resistant epithelial ovarian cancer, a type that returns or progresses within about six months of platinum-based chemotherapy.
Corcept said it expects to make Lifyorli available to patients within a week at a list price of $37,900 for a 28-day cycle, which includes nine treatment doses.
Lifyorli works by blocking cortisol-related stress signals in the body, a mechanism that can make cancer cells more responsive to chemotherapy.
The regulatory approval was based on a late-stage trial involving 381 patients. The data showed those treated with the combination lived a median of 16 months, compared with 11.9 months for patients receiving chemotherapy alone.
Patients are advised to take 150 mg of the drug on the day before, the day of, and the day after each infusion of nab-paclitaxel, the FDA said.
The treatment carries warnings for low white blood cell counts, serious infections, adrenal insufficiency and potential harm to unborn babies, and should not be used in patients who rely on steroid medications to survive.
UBS analyst Ashwani Verma viewed the approval, which came three months ahead of schedule, as a positive, but said a contraindication for patients on steroid medications could be a hurdle and estimated its peak sales of about $550 million.
In December, the FDA had declined to approve relacorilant for hypertension linked to Cushing's syndrome, saying the drug failed to outperform a placebo and raised concerns about potential liver injury - a setback that sent the company's shares plunging about 50%.
