US FDA Approves ‘Glowing Tumor’ Imaging Medication for Lung Cancer Surgery

The targeted imaging agent Cytalux (pafolacianine) has been approved by the US Food and Drug Administration (FDA) for use in lung cancer surgery. When activated by near-infrared light, this injectable diagnostic attaches to diseased tissue and glows, making it easier for surgeons to remove tumors completely while sparing good tissue.

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Glowing Imaging Agent in Lung Cancer

Thoracic surgeons from the University of Pennsylvania’s Abramson Cancer Center’s Center for Precision Surgery led clinical trials evaluating the imaging agent in lung cancer in collaboration with the Indiana-based company, On Target Laboratories. This is Cytalux’s second approval, after one for ovarian cancer surgery last year, which was also based on clinical research in which Penn Medicine headed one of the largest sites in the country.

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Benefits of Using Glowing Imaging Agents in Cancer Surgery

“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 Sunil Singhal, M.D., the William Maul Measey Professor in Surgical Research and director of the Center for Precision Surgery at Penn Medicine. “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.”

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Lung Cancer Prognosis

Lung cancer kills more than 130,000 Americans each year, making it the leading cause of cancer death in the country. Lung cancer mortality is high in part because it is often discovered late in the disease’s progression. Approximately 20% of cases, or approximately 50,000 cases per year, are localized enough to be treated surgically in the hope of a cure. Even with surgery, however, there is a substantial risk of recurrence, implying that normal visual and tactile inspection frequently fails to discover all malignant cells.

How Cytalux Helps in Tumor Removal Surgeries

Cytalux was created to improve this detection rate in tumor removal procedures. The imaging medication is given to the patient before surgery and binds to a surface protein called folate receptor alpha, which is overexpressed in lung cancers and other types of tumors. The imaging agent is designed to emit a luminous emission when illuminated with infrared light, which can be detected by a particular infrared camera. The camera outputs a real-time display, which improves the surgeon’s ability to detect potentially malignant tissue. This is referred to as intraoperative molecular imaging.

The randomized Phase III ELUCIDATE trial (NCT04241315), which concluded last year, found that the imaging agent detected cancer that traditional approaches would have missed in more than half of patients with proven or suspected lung cancer. Singhal was the study’s primary investigator, and the findings were presented at the American Association for Thoracic Surgery Annual Meeting in May 2022.

Penn Medicine has led the field of intraoperative imaging, driving breakthroughs that will allow this imaging agent to be available to patients. Singhal, a pioneer in the field of tumor imaging, has been working with Cytalux for more than a decade, driving efforts to investigate it in hundreds of surgeries for ovarian and lung cancer, in both clinical trials and exploratory investigations. Other novel methods for imaging brain, breast, head and neck, and urinary tract tumors have been created by the Center for Precision Surgery and its affiliated Penn Medicine experts.

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

Source-Medindia