What is it prescribed for?
LUMISIGHT, approved on April 17, 2024, is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.
What is the name of the drug and what does it do?
Lumisight (pronounced loo-MI-site), (generic name: pegulicianine), is a medication indicated for fluorescence imaging in adults with breast cancer.
It is used as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following the removal of the primary specimen during lumpectomy surgery.
How does it work?
Lumisight is an optical imaging agent. It works by binding to specific enzymes (cathepsins and matrix metalloproteases) that are more active in and around cancer cells than in normal cells. When these enzymes cleave Lumisight, it produces fluorescent metabolites that emit light, allowing surgeons to visually detect cancerous tissue during surgery.
This helps ensure that more cancerous tissue is removed, potentially reducing the likelihood of recurrence.
What did the research discover?
Clinical trials demonstrated that Lumisight effectively aids in the detection of residual cancerous tissue during lumpectomy.
In a study involving 406 adult patients with confirmed invasive breast cancer or ductal carcinoma in situ (DCIS), 46% of patients had at least one Lumisight-guided shave, and 7.6% of patients had residual cancer confirmed by histopathology in at least one Lumisight-guided shave.
This shows Lumisight’s potential in enhancing surgical precision and reducing the risk of leaving behind cancerous tissue.
What are some of the side effects?
- Hypersensitivity reactions
- Chromaturia (blue/green discoloration of urine)
- Skin discoloration after extravasation
- Nausea
- Dyspnea (difficulty breathing)
- Pyrexia (fever)
- Vomiting
What are the dosage recommendations and how is it prescribed?
Lumisight is administered as an intravenous injection. The recommended dose is 1 mg/kg of actual body weight, given over 3 minutes, administered 2 to 6 hours prior to imaging.
Preparation involves reconstituting the lyophilized powder with 0.45% Sodium Chloride Injection, USP.
The prepared solution should be a clear, dark blue color. It should be protected from light and used within 4 hours if stored at room temperature or within 24 hours if refrigerated.
Source:
Lumicell, Inc. Lumisight (pegulicianine) for injection, for intravenous use. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214511s000lbl.pdf
