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FDA Approves Pafolacianine to Aid Lung Cancer Surgery


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The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent pafolacianine (Cytalux) for use in lung cancer surgery. This injectable diagnostic binds to cancerous tissue and glows when stimulated by near-infrared light, making it easier for surgeons to remove tumors completely, while sparing healthy tissue.

Thoracic surgeons at the Center for Precision Surgery in the Abramson Cancer Center at the University of Pennsylvania led the clinical trials evaluating the imaging agent in lung cancer, in a partnership with the Indiana-based manufacturer On Target Laboratories. This is the second approval for pafolacianine, following an approval last year for ovarian cancer surgery.

“The availability of this imaging agent has major implications for thoracic surgery and [patients with] lung cancer, who make up the vast majority of thoracic surgery cases,” said Sunil Singhal, MD, 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.”

More than 130,000 Americans die of lung cancer each year, making lung cancer the leading cause of cancer mortality in the country. Lung cancer mortality is high largely because it tends to be diagnosed at later stages when the tumor has begun to spread. About 20% of cases—or roughly 50,000 per year—are localized enough to be treated surgically, in the hope of a cure. But even with surgery, there is a high chance of recurrence, which implies that standard visual and tactile inspection often fails to detect all cancerous tissue.

Pafolacianine was designed to enhance this detection rate in surgeries where the tumor is removed. The imaging drug is infused into the patient preoperatively and binds to a surface protein called the folate receptor alpha (FRα), which is expressed at abnormally high levels in lung tumors and several other types of malignancies. The imaging agent is designed so that under illumination with infrared light, it will produce a glowing emission that can be detected by a special infrared camera. The camera outputs to a real-time display, enhancing the surgeon’s ability to see probable cancerous tissue. This type of technology is known as intraoperative molecular imaging.

ELUCIDATE Trial

The randomized phase III ELUCIDATE trial (ClinicalTrials.gov identifier NCT04241315), completed last year, showed that the imaging agent helped detect cancer that would have been missed by conventional techniques in more than 50% of patients with confirmed or suspected lung cancer. Dr. Singhal was the principal investigator of the multisite study and presented the results at the American Association for Thoracic Surgery Annual Meeting in May 2022 (Abstract LB9).

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

Disclosure: Funding for Cytalux clinical studies conducted at Penn and the Center for Precision Surgery was provided by On Target Laboratories.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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