The FDA has approved a new indication for pafolacianine (Cytalux®, On Target Laboratories), a diagnostic agent, for the identification of lung cancer lesions in adult patients with known or suspected lung cancer who are undergoing surgery. Administered intravenously prior to surgery, pafolacianine is designed to locate additional hard-to-detect lung cancerous tissue.
The safety and efficacy of pafolacianine were evaluated in the randomized, multicenter, open-label, phase 3 ELUCIDATE trial (NCT04241315), which enrolled 140 patients with known or suspected lung cancer who were scheduled to receive thoracoscopic resection or open segmental or subsegmental resection for primary lung lesions that were confirmed or suspected to be cancerous. Patients were administered one intravenous infusion of 0.025 mg/kg pafolacianine between one and 24 hours before surgery.
The primary end point measured was the proportion of patients experiencing a clinically significant event, defined as an unexpected event of pafolacianine detecting cancer that would have been missed using standard surgical practice. Among 110 patients who were administered pafolacianine and were evaluated under both normal and fluorescent light during surgery, 24% of patients had at least one cancerous lesion identified that had not been observed using standard visual or tactile inspection.
The most common adverse events with pafolacianine were infusion-related reactions, which included nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching, and hypersensitivity. Patients should avoid taking folate, folic acid, or folate-containing supplements within 48 hours of administration. The prescribing information for pafolacianine notes the risk of image interpretation errors during surgery, including false negatives and false positives.
"Pafolacianine represents a first-in-class targeted imaging agent to aid the surgeon during surgery to visualize otherwise undetected cancers in the lung," concluded Sunil Singhal, MD, Chief of the Division of Thoracic Surgery at the University of Pennsylvania Perelman School of Medicine, and colleagues, in their abstract of the trial which was presented at the American Association for Thoracic Surgery 102nd Annual Meeting in May 2022. "These findings suggest the use of intraoperative molecular imaging with pafolacianine may be a significant potential advancement to use during standard-of-care lung cancer surgery."
The recommended dosage of pafolacianine is 0.025 mg/kg administered intravenously over 60 minutes, between one and 24 hours prior to surgery.
For More Information
Singhal S, Martin L, Rice D, et al (2022). Randomized, multi-center phase 3 trial of pafolacianine during intraoperative molecular imaging of cancer in the lung: results of the ELUCIDATE trial. Presented at: The American Association for Thoracic Surgery 102nd Annual Meeting. Abstract LB9.
Clinicaltrials.gov (2022). ELUCIDATE: enabling lung cancer identification using folate receptor targeting (ELUCIDATE). NLM identifier: NCT04241315.
Cytalux® (pafolacianine) prescribing information (2022). On Target Laboratories. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214907s002lbl.pdf
US Food & Drug Administration (2022). FDA approves imaging drug to help identify lung cancer lesions. Available at: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-imaging-drug-help-identify-lung-cancer-lesions
Image credit: James Hellmann, MD. LIcensed under CC BY-SA 4.0