Recently, the U.S. Food and Drug Administration (FDA) approved pegulicianine (Lumisight) for adult patients with breast cancer to assist in the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy. Pegulicianine is a fluorescent imaging drug that is administered via intravenous injection before surgery.
The new product is used with the Lumicell Direct Visualization System (DVS) or another fluorescence imaging device that is FDA-approved for use with pegulicianine for breast lumpectomy surgery.
INSITE
The efficacy and safety of pegulicianine were evaluated in a multicenter, intrapatient controlled clinical trial called INSITE (ClinicalTrials.gov identifier NCT03686215), which included patients with breast cancer undergoing lumpectomy surgery. A total of 357 patients underwent image-guided surgery with the Lumicell DVS following standard-of-care lumpectomy. When a positive pegulicianine signal was detected, the tissue was resected with a cavity shave procedure.
The study assessed the proportion of patients receiving pegulicianine who had residual cancer detected and removed after the standard-of-care lumpectomy. A total of 27 of 357 patients (7.6%) had cancer in at least one pegulicianine-guided shave. The study also assessed the image-level sensitivity (ability to designate an imaged region with disease as positive) and specificity (ability to designate an imaged region without disease as negative) for detection of cancer in the lumpectomy cavity. Sensitivity was 49.1% and specificity was 86.5%. Forty-three percent of patients had at least one false-positive image and 8% of patients had at least one false-negative image.
Safety
The most clinically important adverse reaction to pegulicianine was hypersensitivity (in 1.4% of patients), including anaphylaxis (0.6%), identified with a boxed warning in pegulicianine’s prescribing information. Before administration of pegulicianine, all patients should be assessed for any history of hypersensitivity reaction to contrast media or products containing polyethylene glycol, as these patients may have an increased risk for hypersensitivity reaction to pegulicianine. Emergency resuscitation drugs, equipment, and trained personnel should always be available. Additionally, all patients should be monitored for hypersensitivity reactions after pegulicianine administration.
Another common adverse reaction to pegulicianine was chromaturia (85%). There is also a risk of misdiagnosis with the use of pegulicianine to detect residual cancer, including false-negative and false-positive findings.
Pegulicianine received Fast Track designation and Priority Review for this indication.
