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FDA Medication Tracker

← All approvals · Diagnostic & imaging agents · 2024

Lumisight (pegulicianine)

The FDA approved Lumisight (pegulicianine) on April 17, 2024 to use as an optical imaging agent for the detection of cancerous tissue.
Brand name
Lumisight
Generic name
pegulicianine
FDA approval date
April 17, 2024
Approved use (FDA wording)
To use as an optical imaging agent for the detection of cancerous tissue
Company
Lumicell
Application
NDA214511
Dosage form / route
POWDER · INTRAVENOUS
Boxed warning on label
Yes (see the FDA label)
Category on this site
Diagnostic & imaging agents

Indications and usage, from the FDA label

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. 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. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.