FDA approves imaging drug to assist in detection of cancerous tissue following lumpectomy

Action

FDA has approved Lumisight (pegulicianine) in adults with breast cancer to assist the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. Lumisight is a fluorescent imaging drug that is administered in the form of an intravenous injection before surgery.

Lumisight 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.

Disease or Condition

Breast cancer is the most common cancer in women in the U.S., except for skin cancer. The American Cancer Society estimates there will be approximately 310,000 new cases of invasive breast cancer and more than 42,000 deaths in women from this disease in 2024. Treatment for breast cancer includes surgery, radiation, chemotherapy, hormone therapy, and more.

Efficacy

The efficacy and safety of Lumisight were evaluated in a multicenter, intra-patient controlled clinical trial (NCT03686215) of 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 positive Lumisight signal was detected, the tissue was resected with a cavity shave procedure.

The study assessed the proportion of patients receiving Lumisight 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 Lumisight-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 (43%) 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 Lumisight was hypersensitivity (1.4%), including anaphylaxis (0.6%), identified with a boxed warning in Lumisight’s prescribing information. 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.

Another common adverse reaction to Lumisight was chromaturia (abnormal urine color, 85%). There is also a risk of misdiagnosis with the use of Lumisight to detect residual cancer, including false negative and false positive findings.

Designations

Lumisight received Fast Track and priority review for this indication.