The FDA approved the "luminescent tumor" imaging drug to help with lung cancer surgery

The U.
S.
Food and Drug Administration (FDA) has approved the targeted imaging agent Cytalux (pafolacianine) for lung cancer surgery
.
This injectable diagnostic instrument, which binds to cancerous tissue and glows under the stimulation of near-infrared light, makes it easier for surgeons to completely remove tumors while preserving healthy tissue
.

Thoracic surgeons at the Center for Precision Surgery at Abramson Cancer Center at the University of Pennsylvania, in collaboration with Indiana-based manufacturer On Target Laboratories, led clinical trials
evaluating imaging agents for lung cancer 。 This is the second approval for Cytalux, which was approved for ovarian cancer surgery last year and is also based on clinical research, and the University of Pennsylvania School of Medicine leads one of
the largest research centers in the country.

"The availability of this imaging agent has significant implications for thoracic surgery and lung cancer patients, who account for the vast majority of thoracic surgery cases," said
Sunil Singhal, a research professor of surgery and director of the Center for Precision Surgery at the University of Pennsylvania.
"This will allow us to perform less invasive surgeries, detect additional cancers, and detect any remaining cancers more accurately, potentially saving patients from reoperation or additional treatment
.
"

More than 130,000 Americans die of lung cancer each year, making lung cancer the leading cause
of cancer death in the United States.
Lung cancer has a high mortality rate, in large part because it is often diagnosed late when the tumor begins to spread
.
About 20% of cases, or about 50,000 per year, are localized and can be treated surgically in the hope of cure
.
But even after surgery, the chances of recurrence are high, meaning that standard visual and tactile examination often fails to detect all cancerous tissue
.

Cytalux is designed to improve the detection rate
of tumor removal surgery.
This imaging drug is injected into the patient before surgery and binds to a surface protein called folate receptor α (FRα), which is abnormally expressed in lung tumors and several other types of
tumors.
This imaging agent is designed so that, when irradiated with infrared light, it produces a luminous emitt that can be detected by special infrared cameras
.
The camera output to a real-time display enhances the surgeon's ability to
see potentially cancerous tissue.
This technique is called intraoperative molecular imaging
.

A randomized phase III clinical trial (NCT04241315) completed last year showed that the imaging agent could help detect cancers that may have been missed by traditional techniques in more than 50 percent of patients with confirmed or suspected lung cancer
.
Singel was the principal investigator of the multi-site study and presented the findings at the
American Society for Thoracic Surgery Annual Meeting in May 2022.

The University of Pennsylvania School of Medicine is leading the field in intraoperative imaging, driving advances
in bringing this imaging agent to patients.
A pioneer in the field of tumor imaging, Singel has worked with Cytalux for nearly a decade, spearheading hundreds of surgical studies
in clinical trials and exploratory studies for ovarian and lung cancer.
Researchers at the Center for Precision Surgery and its affiliated University of Pennsylvania School of Medicine have also developed several other innovative techniques for imaging
brain, breast, head and neck, and urinary tract cancers.

"Today's approval gives thoracic surgeons a new tool to accurately detect and remove cancer tissue while preserving healthy lung tissue
," Singel said.
"With intraoperative molecular imaging, our ultimate goal is to improve patient care
through more precise surgery.
"

Editor's note: Funding for Cytalux's clinical research at the University of Pennsylvania and the Center for Precision Surgery is provided by On Target Labs
.