OnCo
drugsProductNot mapped hereapproved

Pegulicianine

A cavity-imaging dye used during breast lumpectomy to spot leftover tumour before the operation ends, reducing second surgeries.

INSITE trial (NEJM Evidence 2023): residual tumour found in 7.6% of patients after standard lumpectomy, avoiding some re-excisions (sensitivity 49%, specificity 86%). Approved April 2024 with the Lumicell direct visualisation system. Anaphylaxis risk noted.

Schematic of the modality · Protease-activated fluorescent imaging agent · not a molecule; see the Fluorescence-guided surgery page
Modality
Protease-activated fluorescent imaging agent
Mechanism
PEGylated quenched dye cleaved by cathepsins and MMPs abundant in tumour and tumour-associated cells, fluorescing in the lumpectomy cavity to reveal residual cancer.
Brand / code
Lumisight
Medicare
Part B (clinician-administered)

Intraoperative imaging agent for breast lumpectomy margin assessment, bundled into the surgical payment; hospital outpatient use had a pass-through payment code after approval.

Commercial insurance
variable

Bundled into the surgical claim; some plans consider it investigational.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Inpatient hospital care (Part A). Not medical or financial advice; verify with your plan.

Not appraisedSearch NICE
Notes
No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
NHS England
Not routinely funded

Sources: NICE search: pegulicianine. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2024Fluorescence imaging in adults with breast cancer as an adjunct for intraoperative detection of residual cancer after lumpectomy

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Pegulicianine
intervention: Pegulicianine
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Pegulicianine" OR ABSTRACT:"Pegulicianine" OR TITLE:"Lumisight" OR ABSTRACT:"Lumisight") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Pegulicianine, not a curated reading list.

Connected

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