FDA Approves "Glowing Tumor" Imaging Drug to Better Identify Ovarian Cancer Cells Using Approach Pioneered by Surgeons at the University of Pennsylvania

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11/30/2021

Photo: University of Pennsylvania

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The U.S. Food and Drug Administration (FDA) today approved an imaging drug known as Cytalux (pafolacianine), which is attracted to ovarian cancer tissue and illuminates it when exposed to fluorescent light, allowing surgeons to more easily find and more precisely remove the cancer. Physicians at the Center for Precision Surgery in the Abramson Cancer Center at the University of Pennsylvania led one of the largest clinical trial sites in the country for the drug, in a partnership with the Indiana-based On Target Laboratories. The approach brings fresh hope to patients diagnosed with ovarian cancer, about half of whom experience a recurrence of their disease after initial treatment.

Penn investigators and other industry partners have pioneered additional targeted imaging technologies for lung, brain, breast, sarcoma, head and neck, and urinary tract cancers.

Only 20 percent of ovarian cancers are found early, as there are often no symptoms – or they may mimic other common bladder, bowel, or gastrointestinal issues – and there is no screening test like those for breast and cervical cancer. By the time most women receive their diagnosis, the disease has advanced, which can include spread to intra-abdominal organs. Most patients then require surgery — also called cytoreduction, or debulking surgery — in an effort to remove tumors, as well as receiving chemotherapy.

“Lighting up cancer, which helps to identify lesions that may be difficult to find—especially in the presence of scar tissue or other organ damage—enables more complete identification and surgical removal of cancer that could have otherwise been missed,” said Janos L. Tanyi, MD, PhD, an Associate Professor of Obstetrics and Gynecology in the Perelman School of Medicine at Penn and Principal Investigator at Penn’s clinical trial site for Phase 2 and Phase 3 studies. “This FDA approval offers more precise surgical intervention for patients with ovarian cancer who face a high risk of recurrence after their initial treatment.”

In the randomized, multi-center Phase 3 study, nearly 27 percent of the 134 adult women highly suspicious for, or with confirmed ovarian cancer, who received Cytalux – which is administered intravenously prior to surgery – and were evaluated under both normal and fluorescent light had at least one cancerous lesion detected that was not discovered by standard inspections through sight or touch during surgery and on tissue that was not planned for removal.

By using the new technology to illuminate tumors, surgeons have a guide that allows them to go beyond what they can otherwise see with the naked eye or feel, particularly when lesions are small. This provides not only greater precision in the removal of cancer lesions but also spares healthy tissue.

Sunil Singhal, MDDirector of the Center for Precision Surgery at the Abramson Cancer Center and William Maul Measey Professor in Surgical Research, began searching more than a decade ago for a targeted method to visualize rogue cancer cells, beyond what surgeons could see with the naked eye or feel with the fingers. The Center for Precision Surgery and researchers from its half-dozen affiliated labs have developed several other targeted imaging technologies since its founding in 2015.  The Penn physicians and researchers have tested these approaches in clinical studies involving more than 1,200 patients at Penn to date.

“By using a fluorescent dye that binds to cancer cells, making them glow during surgery, surgeons can identify and resect as much of a patient’s tumors as possible, which is an important step to improve prognosis,” Singhal said. “At every step in their treatment, we want to help offer patients the very best possible outcomes, and this approach is an important step toward greater precision during surgery for ovarian cancer, and, as our studies for other indications continue, in an array of different cancers.”

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