Targeted imaging agent for lung cancer surgery approved by FDA

pharmafile | December 19, 2022 | News story | Research and Development  

The FDA has approved Cytalux (pafolacianine) to be used in lung cancer surgery: the targeted imaging agent binds to cancerous tissues, glowing under near-infrared light, making it easier for the surgeon to remove tumours in their entirety while leaving the healthy tissue alone.

Clinical trials were held by thoracic surgeons at the Center for Precision Surgery in the Abramson Cancer Center at the University of Pennsylvania, US, in which they assessed the imaging agent in lung cancer. The trials were in collaboration with Indiana-based manufacturer, On Target Laboratories. Cytalux was also approved for ovarian cancer last year.

The randomised phase 3 ELUCIDATE trial showed that the imaging agent detected cancer that would have otherwise been missed using conventional techniques in at least 50% of patients with either confirmed or suspected lung cancer.

Sunil Singhal, MD, the William Maul Measey Professor in Surgical Research and director of the Center for Precision Surgery at Penn Medicine, commented: “The availability of this imaging agent has major implications for thoracic surgery and lung cancer patients, who make up the majority of thoracic surgery cases. 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.”

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


Betsy Goodfellow

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