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FDA Expands Approval for Cytalux Imaging for Lung Cancer Detection

FDA Expands Approval for Cytalux Imaging for Lung Cancer Detection
The FDA has approved a new indication for pafolacianine (Cytalux) to aid surgeons in detecting lung cancer lesions in adult patients with known or suspected lung cancer.

The label expansion is based on safety and efficacy findings from the randomized, multi-center, single dose, open-label phase 3 ELUCIDATE trial (NCT04241315) evaluating the use of pafolacianine in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer. Trial results demonstrated that of the 110 patients who received a dose of pafolacianine and were evaluated under normal and fluorescent light during surgery, 24% had at least 1 cancerous lesion detected that was not identified by standard visual or tactile inspection.

“[This] approval of an expanded indication for Cytalux marks an important step forward in the treatment landscape for lung cancer and for the more than 220,000 people in the US who receive a lung cancer diagnosis each year,” said Chris Barys, president and chief executive officer of On Target Laboratories, Inc in a press release. “We are proud to continue pioneering development of targeted intraoperative molecular imaging agents that illuminate cancers intraoperatively to enhance surgeons' ability to see cancer in real time as they operate.”

Pafolacianine was designed to improve the ability to locate additional lung cancer tissue that is difficult to detect during surgery. The drug is comprised of a near-infrared dye and a targeting ligand that binds to receptors overexpressed on cancer cells. The diagnostic agent, administered as an intravenous injection prior to surgery, illuminates cancerous tissue, allowing surgeons to detect more cancer that may have otherwise gone unidentified.

The FDA previously granted a priority review designation to pafolacianine for this indication, and in November 2021, the agency approved pafolacianine to identify ovarian cancer lesions. Pafolacianine remains the first and only targeted molecular imaging agent that highlights lung and ovarian cancer intraoperatively, according to On Target Laboratories, the developer of the imaging tool.

Regarding safety, the most frequent adverse effects of pafolacianine were infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching and hypersensitivity.

Per the FDA label, pafolacianine may cause fetal harm when administered to a pregnant woman. The use of folate, folic acid, or folate-containing supplements should be avoided within 48 hours before administration of Cytalux.

There is also risk of image interpretation errors with the use of pafolacianine to detect lung cancer during surgery, including false negatives and false positives.

“During the ELUCIDATE Trial, Cytalux proved to be a valuable surgical tool with its ability to localize lung lesions that may have otherwise been missed,” Linda Martin, MD, chief of thoracic surgery at the University of Virginia School of Medicine, said in a news release.2 “Cytalux has potential to become standard of care in thoracic surgery because of the safety and efficacy demonstrated in the trial. It is an important tool for surgeons to consider for patients.”


1. FDA approves imaging drug to help identify lung cancer lesions. News release. FDA. December 16, 2022. Accessed December 19, 2022. https://bit.ly/3v0o1fh

2. On Target Laboratories Announces Expanded Indication of CYTALUX® (pafolacianine) injection for Detection of Lung Cancer During Surgery. News release. On Target Laboratories, Inc. December 16, 2022. Accessed December 19, 2022. https://prn.to/3V43lhb

Dec 20, 2022

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