Women's Health

FDA Approves New Diagnostic Drug for Identifying Ovarian Cancer Tissue

The US Food and Drug Administration (FDA) has approved pafolacianine (cytalux) to assist surgeons in identifying ovarian cancer lesions. The imaging drug is designed to improve the surgeon’s ability to locate additional cancerous tissue in the ovaries, which is normally difficult to detect.

Pafolacianine is approved for use in adults with ovarian cancer. It is intended to be used as a diagnostic tool to help identify cancerous lesions during surgery. The drug is administered intravenously prior to surgery. The most common adverse effects reported in clinical trials were infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching and hypersensitivity.

“The FDA’s approval of Cytalux can help enhance the ability of surgeons to identify deadly ovarian tumors that may otherwise go undetected,” said Alex Gorovets, MD, deputy director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research, 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.”

—Amanda Balbi


FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions. News Release. US Food and Drug Administration; November 29, 2021. Accessed December 2, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-new-imaging-drug-help-identify-ovarian-cancer-lesions

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