X-ray style image of the top part of a woman's body showing the lungs highlighted and four red lung cancer tumors of different sizes
Credit: Shubhangi Ganeshrao Kene/ Science Photo Library/ Getty Images

On Friday, the U.S. Food and Drug Administration (FDA) approved the imaging agent Cytalux (pafolacianine) for use in lung cancer cases to help surgeons find and remove previously unidentified tumors. The expanded use of the drug, developed and marketed by On Target Laboratories, comes roughly a year after its initial approval for use for ovarian cancer tumor imaging.

“Today’s approval of an expanded indication for Cytalux marks an important step forward in the treatment landscape for lung cancer and for the more than 220,000 people in the U.S. who receive a lung cancer diagnosis each year,” said Chris Barys, president and CEO of On Target Laboratories. “We are proud to continue pioneering development of targeted intraoperative molecular imaging agents that illuminate cancers intraoperatively to enhance surgeons’ ability to see cancer in real time as they operate.”

The approval comes at the completion of the multi-center, single-dose, open label Phase III ELUCIDATE (Enabling LUng Cancer IDentification Using FolATE Receptor Targeting) clinical trial. Led by Sunil Singhal, MD, a professor of surgical research and director of the Center for Precision Surgery at Penn Medicine,  the trial—which included a dozen other clinical centers—showed that the imaging agent helped detect cancer that would have been missed by conventional techniques in more than 50 percent of patients with confirmed or suspected lung cancer.

The availability of this imaging agent has major implications for thoracic surgery and lung cancer patients, who make up the vast majority of thoracic surgery cases,” said Singhal, MD. “It will allow us to do less invasive operations, find additional cancer, and more accurately detect any remaining cancer, potentially saving patients from reoperation or additional therapy.”

Cytalux was designed to enhance the detection rate in surgeries where tumors are removed. The imaging drug is infused into the patient pre-operatively, and binds to a surface protein called the folate receptor alpha (FRα), which is expressed at abnormally high levels in lung tumors and as well as other kinds of tumors. The imaging agent is designed to produced to glow under illumination with infrared light that can be detected by specially designed camera. The camera, in turn, outputs these images to a real-time display, enhancing the surgeon’s ability to see probable cancerous tissue.

This second approval for the imaging agent is helping to usher in a new era in the use of intraoperative molecular imaging (IMI) that allows doctors to more precisely visualize and remove cancerous tumors during surgery that might have otherwise been missed using traditional means.

“During the ELUCIDATE Trial, Cytalux proved to be a valuable surgical tool with its ability to localize lung lesions that may have otherwise been missed,” said Dr. Linda Martin, chief of Thoracic Surgery, University of Virginia School of Medicine. “CYTALUX has potential to become standard of care in thoracic surgery because of the safety and efficacy demonstrated in the trial.  It is an important tool for surgeons to consider for patients.”

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