FDA Approves Lumisight to Help Find Cancer

FDA has approved Lumicell’s Lumisight (pegulicianine) for use in adults with breast cancer to assist in the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during a lumpectomy. An agency statement says Lumisight is a fluorescent imaging drug that is administered through an intravenous injection before surgery. It is used with the Lumicell Direct Visualization System or another fluorescence imaging device that is FDA-approved for use with pegulicianine for breast lumpectomy surgery.

Lumisight’s efficacy and safety were evaluated in a trial of 357 patients with breast cancer undergoing lumpectomy. The statement says the most clinically important adverse reaction to Lumisight was hypersensitivity, including anaphylaxis, which is the subject of a Boxed Warning in the labeling.

FDA says Lumisight received fast track and priority review designations for this indication.