FDA Approves “Glowing Tumor” Drug for Ovarian Cancer Surgery

By Pat Carragher - December 06, 2021

Surgeons have a new tool to help in the fight against ovarian cancer. Cytalux, a dye that binds to ovarian cancer tissue and glows when exposed to fluorescent light, has received approval from the U.S. Food and Drug Administration.

Moffitt Cancer Center was one of the trial sites for the drug designed to help surgeons detect ovarian tumors during surgical procedures in patients.

“The FDA approval of Cytalux is a significant milestone that will advance the way we detect cancer,” said Dr. Robert Wenham, chair of Moffitt’s Gynecologic Oncology Program. “We know that survival is better with the more cancer that is removed. We helped show that this technology can help us find more cancer and is truly a game changer.”

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"We helped show that this technology can help us find more cancer and is truly a game changer."

- Dr. Robert Wenham, Chair, Gynecologic Oncology Program

According to the American Cancer Society, more than 21,000 women will be diagnosed with ovarian cancer in the United States this year. For most of them, surgery will be recommended to remove all visible disease.

Sometimes spots of cancer can camouflage themselves and make them difficult to detect with the naked eye. Cytalux uses a fluorescent dye that targets a molecule on many ovarian cancers to help better identify those hard-to-find cancer cells. The drug is is administered in the form of an intravenous injection prior to surgery.

Previously, surgeons relied on preoperative imaging, visual inspection of tumors under normal light or examination by touch to identify cancer lesions. With the approval, Moffitt’s gynecological surgeons will be able to use a near-infrared camera to see those cancerous tissues in real time that may otherwise go undiscovered.

“The removal of more tumor is associated with better survival for patients,” said Wenham. “If we’re able to detect this using fluorescence, you might be able to see disease that you couldn’t with the naked eye.”

In the Phase 3 study, nearly a third of the women who had suspected or confirmed ovarian cancer and received Cytalux had at least one cancerous lesion detected under fluorescent light that was not discovered by standard inspections.

“The multidisciplinary experts at Moffitt were instrumental in the development of this technology as active investigators in the Phase 2 and randomized Phase 3 studies,” said Wenham. “Our tissue core lab served as their central lab for study. There is a learning curve to the technology, but since we helped establish it over the last few years, we are going to be leading the application of this to benefit patients.”

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