FDA Approves Illuminating Drug to Find Ovarian Cancer Cells

By the time most women receive their diagnosis, ovarian cancer may advance, 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.

“This FDA approval offers promise in improving outcomes for patients with ovarian cancer who face a high risk of recurrence after their initial treatment.”

Around 27 percent of the 134 adult women who received the diagnostic agent Cytalux – which is given IV before 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.

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. The newly approved dye also helps surgeons to find cancerous lymph nodes.

Sunil Singhal started searching for a targeted method to visualize rogue cancer cells, beyond what surgeons could see with the naked eye or feel with the fingers.

The answer would arrive from his studies into tumor permeability and small molecule retention. What separates this agent from the prior art was the ability to selectively target cancer cells with a fluorescent contrast agent.

Dr. Singhal explored this hypothesis in clinical studies involving more than 1,000 patients at Penn since 2012. His studies with Cytalux were initiated with preclinical studies before proceeding to humans.

The current investigational series may constitute the largest clinical experience with intraoperative molecular imaging with targeted fluorochromes in the world.

“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 and 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 an array of different cancers.”

Source: Medindia