FDA Approves Imaging Agent to Detect Ovarian Cancer

The FDA has approved Cytalux (pafolacianine), an imaging agent intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery.

To date, there have been limited ways for surgeons to assess the location and extent of cancerous tissue while operating. Developed by On Target Laboratories, Cytalux is comprised of a near-infrared dye and a targeting molecule that binds to receptors overexpressed on cancer cells. Specifically, it targets folate receptors commonly found on many cancers, such as ovarian cancer.

A single dose of the agent is administered via intravenous infusion prior to surgery to help the surgeon identify additional malignant tissue during the operation using a near-infrared imaging system.

“The FDA's approval of Cytalux can help enhance the ability of surgeons to identify deadly ovarian tumors that may otherwise go undetected,” Alex Gorovets, M.D., deputy director of the Office of Specialty Medicine in the FDA's Center for Drug Evaluation and Research, said in a statement. “By supplementing current methods of detecting ovarian cancer during surgery, Cytalux offers health care professionals an additional imaging approach for patients with ovarian cancer.”

The approval was based on a phase 3 study of women diagnosed with ovarian cancer who were scheduled to undergo surgery. Of the 134 women who received a dose of Cytalux, 26.9% had at least one cancerous lesion detected that was previously not observed.

The most common side effects were infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching and hypersensitivity.

The FDA previously granted Cytalux orphan-drug, priority and fast track designations.