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Cytalux Gets Expanded FDA Approval for Intraoperative Imaging of Lung Cancer


Reportedly the first targeted molecular imaging agent to provide intraoperative illumination of lung cancer, Cytalux (pafolacianine) helped identify clinically significant events in more than 50 percent of patients undergoing surgery for confirmed or suspected pulmonary nodules, according to Phase 3 trial data presented earlier this year at the American Association for Thoracic Surgery Annual Meeting.

The Food and Drug Administration (FDA) has granted an expanded approval to the molecular imaging agent Cytalux (pafolacianine) for intraoperative imaging in lung cancer surgery.

On Target Laboratories, the manufacturer of Cytalux, said FDA approval of the expanded indication was based on findings from the ELUCIDATE trial, a Phase 3, multicenter study that examined the use of the imaging agent for patients having thoracic surgery for confirmed or suspected lung cancer.1

According to the ELUCIDATE trial findings, presented earlier this year at the American Association for Thoracic Surgery Annual Meeting, researchers found that that Cytalux helped identify clinically significant events in 54 out of 100 patients that underwent thoracic surgery.2 For 19 patients, Cytalux identified an index lesion that was not detectable with white light, according to the study. Researchers added that intraoperative findings with Cytalux led to changes in the scope of the surgical procedure in 29 percent of patients.2

In a Penn Medicine press release, Sunil Singhai, M.D, the primary investigator for the ELUCIDATE study, called Cytalux a significant imaging advance in thoracic surgery.3

“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,” noted Dr. Singhai, 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 patient from reoperation or additional therapy.”

On Target Laboratories said Cytalux binds to folate receptors that are overexpressed in pulmonary adenocarcinomas and epithelial ovarian cancer. Administered at least one hour prior to surgery, Cytalux was previously cleared by the FDA in November 2021 for intraoperative use in patients with ovarian cancer.


1. On Target Laboratories. On Target Laboratories announces expanded indication of CYTALUX® (pafolacianine) injection for detection of lung cancer during surgery. Cision PR Newswire. Available at: https://www.prnewswire.com/news-releases/on-target-laboratories-announces-expanded-indication-of-cytalux-pafolacianine-injection-for-detection-of-lung-cancer-during-surgery-301705473.html . Published December 16, 2022. Accessed December 19, 2022.

2. Singhai S, Martin L, Rice D, et al. Randomized, multi-center phase 3 trial of pafolacianine during intraoperative molecular imaging of cancer in the lung: results of the ELUCIDATE trial. American Association for Thoracic Surgery Annual Meeting., May 14-17, Boston. Available at: https://www.aats.org/resources/2962 . Published May 17, 2022. Accessed December 19, 2022.

3. FDA approves ‘glowing tumor’ imaging drug to aid lung cancer surgery. Penn Medicine News. Available at: https://www.pennmedicine.org/news/news-releases/2022/december/fda-approves-glowing-tumor-imaging-drug-for-lung-cancer-surgery . Published December 16, 2022. Accessed December 19, 2022.

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