New FDA Approval: LUMISIGHT™ (pegulicianine)
The Food and Drug Administration (FDA) recently 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.
Read InpharmD's summary below:
| Drug Name |
LUMISIGHT™ (pegulicianine) |
| Active Ingredient |
pegulicianine |
| Date of Approval |
04/17/24 |
| Manufacturer |
LUMICELL INC |
| Approval Pathways and Indications |
Indication: LUMISIGHT™ is an optical imaging agent 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.
Approval Pathway: NDA |
| Therapeutic Class |
Imaging Agent |
| Formulation |
Injection |
| MoA |
Pegulicianine is a prodrug that is optically inactive when intact and produces a fluorescent signal after its peptide chain is cleaved by cathepsins and matrix metalloproteases (MMPs). The levels of these enzymes are higher in and around tumor and tumor-associated cells than normal cells.
This enzymatic cleavage results in “fragment 2” and “fragment 3”, which are optically active metabolites that emit fluorescence, as well as “fragment 1” containing the fluorescence quencher that keeps the intact molecule optically inactive. “Fragment 2” and “fragment 3” absorb light in the visible light region with a peak absorption at 650 nm and fluoresce with a peak emission at 675 nm. |
| Dosing and Administration |
For injection: dark blue lyophilized powder in a single-dose vial delivering 39 mg pegulicianine after reconstitution.
• Recommended dose of LUMISIGHT™ is 1 mg/kg by intravenous injection over 3 minutes administered 2 hours to 6 hours prior to imaging. |
| Administered by self or by HCP |
Administered by HCP |
| Place in Therapy |
LUMISIGHT™ is designed for use alongside the investigational Lumicell Direct Visualization System (DVS), aimed at aiding in the detection of residual cancerous tissue within the lumpectomy cavity post-removal of the primary specimen during breast conserving surgery.
The submission of the LUMISIGHT™ NDA is backed by data from over 700 breast cancer patients across five clinical studies conducted at leading academic and regional community cancer centers. Findings from the pivotal Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) trial (NCT03686215), which involved 406 patients at 14 sites, will be presented at the upcoming American Society of Breast Surgeons (ASBrS) annual meeting. Recognizing its potential to identify residual cancer post-initial lumpectomy, the FDA granted LUMISIGHT™ Fast Track designation and the Lumicell DVS Breakthrough Device designation. |
| Expected Market Launch Date |
Anticipated availability is unknown. |
| New Molecular Entity (NME) or Existing Formulation |
NME |
| Expected Cost |
Unavailable |
| Product Discontinuation |
N/A |
| Clinical Trials |
The efficacy and safety of LUMISIGHT™ for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery in patients with breast cancer were evaluated in a randomized, multicenter, intra-patient controlled clinical trial (NCT03686215). The study assessed the proportion of patients receiving LUMISIGHT™ who had residual cancer detected and removed using the Lumicell DVS after completion of Standard of Care (SOC) lumpectomy. A total of 406 adult patients with confirmed invasive breast cancer, ductal carcinoma in situ (DCIS), or both received 1 mg/kg LUMISIGHT™ by intravenous injection 2 hours to 6 hours prior to imaging with the Lumicell DVS. Among them, 357 patients underwent LUMISIGHT™-guided imaging after completion of the SOC lumpectomy procedure.
One hundred and sixty-six (166) of 357 (46%) patients had at least one LUMISIGHT™-guided shave. A total of 27 of 357 patients had residual cancer confirmed by histopathology in at least one LUMISIGHT™-guided shave (7.6%; 95% CI: 5.0%, 10.8%). |
| Sources |
Lumicell submits New Drug Application for LUMISIGHTTM Optical Imaging Agent to U.S. FDA for Intraoperative Breast Cancer Detection and removal. Business Wire. (2023, March 21). https://www.businesswire.com/news/home/20230303005315/en/Lumicell-Submits-New-Drug-Application-for-LUMISIGHT%E2%84%A2-Optical-Imaging-Agent-to-U.S.-FDA-for-Intraoperative-Breast-Cancer-Detection-and-Removal |
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