FDA approves imaging drug for detecting cancer after lumpectomy

Editor's Note

The US Food and Drug Administration (FDA) approved Lumisight (pegulicianine), a fluorescent imaging drug used to detect cancerous tissue during lumpectomy, on April 17.

Administered intravenously prior to surgery, Lumisight is designed for use with the Lumicell Direct Visualization System (DVS) or another imaging device that is FDA-approved for use with pegulicianine for breast lumpectomy.

A multi-center clinical trial of 357 breast cancer patients undergoing image-guided surgery confirmed the drug’s efficacy and safety. Upon detection of a positive signal, tissue was resected via cavity shave. According to the FDA report, 27 of 357 patients undergoing image-guided surgery (7.6%) had cancer in at least one guided shave. Image-level sensitivity (ability to designate an imaged region with disease as positive) was 49.1%, while specificity (ability to designate an imaged region without disease as negative) was 86.5% for detection of cancer in the lumpectomy cavity.

At least one false positives was reported for 43% of patients, and at least one false negative was reported for 8%. According to FDA, “ Before administration of Lumisight, all patients should be assessed for any history of hypersensitivity reaction to contrast media or products containing polyethylene glycol (PEG), as these patients may have an increased risk for hypersensitivity reaction to Lumisight. Emergency resuscitation drugs, equipment, and trained personnel should always be available. Additionally, all patients should be monitored for hypersensitivity reactions after Lumisight administration.”