March 25 (Reuters) - The U.S. Food and Drug Administration on Wednesday approved Corcept Therapeutics' CORT.O drug for women with an aggressive form of ovarian cancer that has stopped responding to standard treatment, the health regulator's website showed.
Shares of the company jumped more than 35% in morning trading.
Here are some details:
The health regulator approved relacorilant, under the brand name Lifyorli, for use alongside a chemotherapy drug called nab-paclitaxel.
The combination is approved for the treatment of adults with platinum-resistant epithelial ovarian cancer, a type of cancer that returns or continues to grow within about six months after treatment with platinum‑based chemotherapy.
The agency's decision was based on a 381-patient trial, where the participants on the combo therapy lived a median of 16 months, compared with 11.9 months on chemotherapy alone.
Lifyorli works by blocking the body's cortisol-related stress signals, which can make cancer cells more sensitive to chemotherapy.
Patients are advised to take 150 mg of Lifyorli on the day before, the day of, and the day after each nab-paclitaxel infusion, the FDA said.
The drug carries warnings for low white blood cell counts and serious infections, adrenal insufficiency, and harm to unborn babies and should not be used in patients who depend on steroid medications to stay alive.