LUMISIGHT 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.

For injection: dark blue lyophilized powder in a single-dose vial delivering 39 mg pegulicianine after reconstitution.

LUMISIGHT is contraindicated in patients with a history of hypersensitivity reaction to pegulicianine. Reactions have included anaphylaxis

The following clinically important adverse reactions are described elsewhere in the labeling:

Blue dyes used for SLN mapping procedures generate a fluorescent signal that interferes with the signal from LUMISIGHT when injected into the breast prior to imaging with LUMISIGHT. The potential of other dyes to interfere with LUMISIGHT imaging has not been evaluated. Avoid administration of dyes used for SLN mapping procedure before imaging the lumpectomy cavity in patients receiving LUMISIGHT.

LUMISIGHT (pegulicianine for injection) is an optical imaging agent for intravenous use.

The chemical name of pegulicianine acetate is N-[6-(1-{2-[3,6-bis(2,3-dihydro-1H-indol-1-yl)xanthylium-9-yl]benzene-1-sulfonyl}piperidine-4-carboxamido)hexanoyl]glycylglycyl-L-arginyl-N6-(6-{2-[(1E,3E,5Z)-5-(1-ethyl-3,3-dimethyl-5-sulfonato-1,3-dihydro-2H-indol-2-ylidene)penta-1,3-dien-1-yl]-3,3-dimethyl-5-sulfonato-3H-indol-1-ium-1-yl}hexanoyl)-Llysyl-[2-(2-aminoethoxy)ethoxy]acetyl-S-[(3RS)-1-{6-[α-methylpoly(oxyethylene)-ω-amino]-6-oxohexyl}-2,5-dioxopyrrolidin-3-yl]-L-cysteinamide acetate with a molecular formula of C

LUMISIGHT is supplied as a sterile, dark blue lyophilized powder. Each vial contains 40 mg of pegulicianine (equivalent to 40.1 mg of pegulicianine acetate) and the following inactive ingredients: 3.2 mg of dibasic sodium phosphate heptahydrate, 39.5 mg of mannitol, and 3.8 mg of monobasic sodium phosphate monohydrate to permit withdrawal of 3.9 mL of pegulicianine 10 mg/mL upon reconstitution with 4 mL of 0.45% sodium chloride injection, USP. The pH of the reconstituted solution is 6 to 7.

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. 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 standard of care lumpectomy procedure. Patients who received neoadjuvant chemotherapy or radiotherapy prior to surgery were excluded from study. After the standard of care (SOC) lumpectomy was completed, the lumpectomy cavity was divided into six regions based on anatomic orientation and each region was imaged with the Lumicell DVS. When positive fluorescence signal was detected, the tissue was resected with a cavity shave procedure and the region was re-imaged. A maximum of two LUMISIGHT-guided shaves were obtained from a single region. Histopathology analysis of excised tissue served as the reference standard. Cavity regions that did not have a LUMISIGHT-guided cavity shave or tissue from a second surgery for a reference standard were assigned the margin status of the corresponding outermost surface of the lumpectomy specimen or SOC cavity shave, with a positive margin defined as tumor on ink for invasive cancers (with or without DCIS) or within 2 mm of the inked margin for DCIS alone.

The mean age of patients was 62 years (range: 36 years to 83 years). Distribution by race was 82% White, 7% Black or African American, 6% Asian, and 5% other. Distribution by ethnicity was 3% Hispanic/Latino, 94% non-Hispanic/Latino, and 3% unknown or unreported. In the study group, 70% of patients had invasive ductal carcinoma (with or without DCIS), 20% had DCIS only, 10% had invasive lobular carcinoma (with or without DCIS), and <1% had both invasive ductal and invasive lobular carcinoma.

The study assessed the proportion of patients receiving LUMISIGHT who had residual cancer detected and removed using the Lumicell DVS after completion of SOC lumpectomy. 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%).

Table 1 shows sensitivity and specificity of LUMISIGHT for residual breast cancer after completion of SOC lumpectomy calculated from the 2,346 evaluable images in the study. Regions of the lumpectomy cavity from which LUMISIGHT-guided shaves were taken contributed more than one image to the analysis.

A total of 155 of 357 (43%) patients had at least one false positive image, and 28 of 357 (8%) patients had at least one false negative image. Among the 166 patients with at least one LUMISIGHT-guided shave, the mean total LUMISIGHT-guided shave volume was 22 cm

After completion of SOC lumpectomy, prior to LUMISIGHT-guided tissue removal, 62 of 357 patients (17%) had at least one cancer-positive margin. After LUMISIGHT-guided surgery, 9 of these 62 (15%) patients changed to having all cancer-negative margins, and 2 of the remaining 295 (1%) patients changed from having all cancer-negative margins to having at least one cancer-positive margin.

How supplied

LUMISIGHT (pegulicianine) for injection is supplied as a dark blue lyophilized powder for reconstitution in a clear, glass single-dose vial in cartons of 10 vials (NDC 82292-040-10). After reconstitution, each vial delivers 39 mg pegulicianine.

Storage and Handling

Store vials of LUMISIGHT frozen at -25°C to -15°C (-13°F to 5°F) in the original carton to protect from light.

Inform patients of the risk of hypersensitivity reactions, including anaphylaxis, and instruct them to alert healthcare providers immediately if they experience signs and symptoms of a hypersensitivity reaction

Inform patients that LUMISIGHT may cause blue discoloration of the urine that in most cases will resolve within 48 hours

Inform patients that if extravasation occurs, it may result in blue discoloration of the skin at the injection site that will be evident for several weeks

Rx Only

LUMISIGHT

Single-Dose vial.

For intravenous use after reconstitution with

After reconstitution, store at room temperature 20°C to 25°C

Rx Only

LUMISIGHT

Single-Dose vial.

For intravenous use after reconstitution with

10 single-dose vials. Discard unused portion.

Storage: Prior to reconstitution, store frozen at -25°C to -15°C (-13°F to 5°F). Store in original carton to protect from light.

Each vial contains 40 mg of pegulicianine (equivalent to 40.1 mg of pegulicianine acetate) and the following inactive