Lumisight and Lumicell DVS Receive FDA Approval to Detect Residual Breast Cancer

Lumisight and Lumicell DVS Receive FDA Approval to Detect Residual Breast Cancer

The optical imaging agent Lumisight (pegulicianine) and the Lumicell Direct Visualization System (DVS) received approval from the FDA for use as fluorescence imaging in adult patients with breast cancer to aide in intraoperative detection of cancerous tissue within the resection cavity after removal of the primary specimen during lumpectomy surgery.¹

Together, Lumisight and Lumicell DVS are referred to as LumiSystem.

Data have shown that Lumisight has demonstrated an 84% diagnostic accuracy in detecting residual cancer in real-time, detecting residual disease that may have been missed during lumpectomy and potentially sparing some patients from additional surgeries.

“We are immensely proud of the dual approval of Lumisight and Lumicell DVS—we believe this is the first drug-device combination product approved in over a decade to have followed both of the FDA's most stringent NDA and PMA review processes,” Howard Hechler, president and chief operating officer of Lumicell, stated in a news release. “With the FDA’s approval, LumiSystem is now the first and only imaging combination product capable of detecting cancerous tissue where it matters most, inside the breast cavity.”

In March 2024, the FDA's Medical Imaging Drugs Advisory Committee voted 16 to 2, with 1 abstention, in favor of the benefit-risk profile of Lumisight in detecting cancerous tissue during breast-conserving surgery. The recommendation was based on an independent review of the imaging agent utilized with the Lumicell DVS, examining efficacy data for more than 350 patients included in the pivotal phase 3 INSITE trial (NCT03686215) and more than 700 patients enrolled across 6 studies conducted at academic and community cancer centers, including a phase 2 feasibility study (NCT03321929).²

INSITE was a prospective study that assessed margin status with or without Lumisight in patients with stage 0 to III breast cancer, where patients were randomly assigned 10:1 to the Lumisight group or control group.³

Among 357 patients who received Lumisight, margins guided by the optical imaging agent allowed for the removal of tumors left behind after standard lumpectomy in 27 patients (7.6%; 95% CI, 5.0%-10.8%). In 19 of these 27 patients, margins were negative on standard lumpectomy pathology evaluation, and the residual cancer would have been unrecognized without Lumisight.

Additionally, 62 patients (19.7%) had at least 1 positive margin. Second surgeries were avoided with the use of Lumisight in 9 patients (14.5%) with positive margins.

A per-margin analysis demonstrated that the Lumisight specificity was 85.2% (95% CI, 83.7%-86.6%), which was higher than the prespecified lower-bound goal of greater than 60%. Notably, the sensitivity was 49.3% (95% CI, 37.0%-61.6%), which failed to meet the prespecified lower-bound goal of greater than 40%.

During the study, 406 patients received 1.0 mg/kg of intravenous Lumisight followed by lumpectomy. In the 392 patients who were randomly assigned, 316 had invasive cancers, and 76 had in situ cancers.

References

1. Lumicell’s cutting-edge imaging platform receives historic FDA approval to illuminate residual breast cancer. News release. Lumicell, Inc. April 18, 2024. Accessed April 18, 2024. https://www.businesswire.com/news/home/20240418089547/en/Lumicell%E2%80%99s-Cutting-Edge-Imaging-Platform-Receives-Historic-FDA-Approval-to-Illuminate-Residual-Breast-Cancer
2. Lumicell announces FDA advisory committee's positive recommendation on the benefit-risk profile of Lumisight in the detection of cancerous tissue during breast conserving surgery. News release. Lumicell, Inc. March 6, 2024. Accessed March 9, 2024. https://lumicell.com/lumicell-announces-fda-advisory-committees-positive-recommendation-on-the-benefit-risk-profile-of-lumisight-in-the-detection-of-cancerous-tissue-during-breast-conserving-surgery/
3. Smith BL, Hunt KK, Carr D, et al. Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery. NEJM Evid. 2023;2(7):EVIDoa2200333. doi:10.1056/EVIDoa2200333