March 5, 2024 Meeting of the Medical Imaging Drugs Advisory Committee (MIDAC)

The committee will discuss efficacy and safety data submitted in support of New Drug Application (NDA) 214511 for LUMISIGHT (pegulicianine), the optical imaging drug constituent of a combination product consisting of LUMISIGHT for injection, and a device constituent, the Lumicell Direct Visualization System (DVS). The proposed indication for LUMISIGHT is for use in patients with breast cancer to assist in the detection of cancerous tissue within the lumpectomy cavity following removal of the primary specimen during lumpectomy surgery.