Approved: New Imaging Rx for Ovarian Cancer

FDA approves Cytalux (pafolacianine) to help with ovarian cancer imaging

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new medication to help surgeons find ovarian cancer lesions.

This new drug is called Cytalux (pafolacianine). The FDA approved it for use during surgery in adults who have ovarian cancer.

Administered intravenously before surgery, Cytalux is meant to help surgeons see lesions caused by ovarian cancer by causing them to illuminate under fluorescent light.

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

Often, patients who have ovarian cancer will produce more of a protein called a folate receptor in their cell membranes. According to the FDA, Cytalux binds to folate receptors and lights up when surgeons use fluorescent light. This helps surgeons identify cancerous tissue. The FDA also approved a fluorescent imaging system to be used with Cytalux.

Before the approval of this medication, surgeons had to rely on conventional tumor identification methods. These include traditional imaging, light-assisted visual inspection and touch.

Cytalux appeared safe and effective in a study of women who had been diagnosed with ovarian cancer or who were highly likely to have it. In the study, 134 women received Cytalux and were examined under both fluorescent and normal light. Nearly 27 percent of these women had a cancerous lesion that was detected via Cytalux and not through standard inspection methods.

Common side effects of Cytalux included reactions at the injection site, itching, stomach pain, indigestion, nausea, vomiting and chest discomfort. This medication is not recommended for use in pregnant women. The FDA also noted that women should avoid taking supplements that contain folate or folic acid two days before they are going to receive Cytalux.

The FDA approved Cytalux for On Target Laboratories, LLC.

Talk to your doctor about the recommended cancer screening schedule.

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Review Date: 
December 1, 2021