Ovarian Cancer Drug Gets Green Light

The U.S. Food and Drug Administration has approved Lifyorli (relacorilant) for adults battling platinum-resistant epithelial ovarian cancer. This aggressive form of the disease typically returns or progresses within six months of platinum-based chemotherapy. The new therapy is administered in combination with the chemotherapy drug nab-paclitaxel.

Lifyorli's mechanism involves blocking cortisol-related stress signals in the body, which can increase cancer cells' responsiveness to chemotherapy. This approval, granted ahead of schedule, was based on a late-stage trial involving 381 patients. Those receiving the combination therapy lived a median of 16 months, compared to 11.9 months for patients on chemotherapy alone.

The FDA has provided specific dosage instructions: 150 mg of Lifyorli on the day before, the day of, and the day after each infusion of nab-paclitaxel. However, the treatment carries warnings for potential side effects including low white blood cell counts, serious infections, adrenal insufficiency, and risks to unborn babies. It is not recommended for patients who depend on steroid medications for survival.

Analysts view the approval positively, though potential hurdles exist due to contraindications. Previous setbacks, including a rejection for a hypertension-related indication in December, had impacted the company's stock. The approved indication represents a significant advancement for patients with limited treatment options.