Dr Park on the FDA Vote Supporting Lumisight Use for Breast Cancer Detection During Surgery

Ko Un “Clara” Park, MD, associate surgeon, Division of Breast Surgery, Director of Research, Breast Surgery Network Sites, Center For Surgery and Public Health, Brigham and Women's Hospital, member, faculty of surgery, Division of Breast Surgery, Harvard Medical School, discusses the FDA's positive recommendation for Lumisight (pegulicianine)-based imaging for patients with breast cancer undergoing breast conserving surgery, and its potential impact on surgical care.

During a meeting on March 5, 2024, the FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) voted 16 to 2 (with 1 abstain vote) in favor of the risk-benefit profile of the optical imaging agent in combination with the Lumicell™ Direct Visualization System to detect residual cancer in real-time during a lumpectomy, Park begins.

The positive recommendation from MIDAC was based on a thorough review of efficacy and safety data provided by the drug's developer, Lumicell, and the FDA. This included data from the pivotal INSITE study (NCT03686215), which involved more than 350 patients with breast cancer, as well as safety findings from more than 700 patients across 6 clinical studies, including a phase 2 feasibility study (NCT03321929).

In the INSITE study, patients received intravenous Lumisight prior to undergoing lumpectomy. The data showed that the margin-level specificity of the agent was 85.2% (95% CI, 83.7%-86.6%), indicating its ability to accurately detect cancerous tissue at the surgical margin. The sensitivity level, which measures the agent's ability to detect cancerous tissue that may have been missed by traditional methods, was 49.3% (95% CI, 37.0%-61.6%).

This latest FDA communication highlights Lumisight's efficacy in reducing positive margins after lumpectomy for breast cancer, Park states. Despite advancements in surgical techniques, positive margins remain a concern in lumpectomy, Park continues. Lumisight offers real-time visualization of the surgical bed during lumpectomy and enhances intraoperative imaging, which could potentially reduce the rate of positive margins, she explains.

The FDA is now expected to review Lumicell's new drug application and premarket approval for Lumisight, and a decision on its approval is anticipated in the near future. If approved, Lumisight has the potential to improve surgical outcomes and decrease the need for additional surgeries or adjuvant treatments, Park concludes.