Lumisight, Lumicell DVS Gains FDA Approval to Detect Residual Breast Cancer

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The FDA has approved Lumisight and the Lumicell Direct Visualization System for fluorescence imaging in adult patients with breast cancer.

  • A new drug application (NDA) and premarket approval (PMA) application for Lumisight (pegulicianine) and the Lumicell Direct Visualization System (DVS) has been granted approval by the FDA as fluorescence imaging in adult patients with breast cancer.

  • Together, Lumisight and Lumicell DVS are known as LumiSystem.

  • LumiSystem is now approved for fluorescence imaging in adult patients with breast cancer to assist in identifying cancerous tissue within the resection cavity after the removal of the primary specimen during lumpectomy surgery.

The FDA has approved the NDA and PMA for Lumisight and the Lumicell DVS. The products are indicated for use as fluorescence imaging in adult patients with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity after the primary specimen has been removed during lumpectomy surgery.1

Lumisight and Lumicell DVS together are referred to as LumiSystem.

This marks the first and only imaging combination product uniquely designed to detect cancerous tissue within the breast cavity, where it is most crucial.

“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 review processes,” said Howard Hechler, president and chief operating officer of Lumicell, in a press 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.”

According to prior data, Lumisight showed an 84% diagnostic accuracy in detecting residual cancer in real-time. The product works by identifying residual disease that may have been missed during lumpectomy, potentially sparing some patients from needing to undergo additional surgeries.

Breast Cancer - Female Anatomy - pain concept: © peterschreiber.media - stock.adobe.com

Breast Cancer - Female Anatomy - pain concept: © peterschreiber.media - stock.adobe.com

The system's safety was established using data from more than 700 breast cancer patients across 5 clinical trials which took place across the US. For adverse events (AEs), the most common included hypersensitivity and an abnormal color in urine. Further, Lumisight may cause serious hypersensitivity reactions, including anaphylaxis.

Additional data from the pivotal INSITE trial (NCT03686215) were used to support the efficacy of the system.2 Here, 406 patients were treated with 1.0 mg/kg intravenous pegulicianine followed by lumpectomy. A total of 316 had invasive cancers and 76 had in situ cancers.

Overall, the use of pegulicianine fluorescence-guided surgery in breast cancer surgery met prespecified thresholds for removal of residual tumor specificity. However, it did not meet the prespecified threshold for sensitivity.

For safety, administration of pegulicianine was stopped due to AEs in 6 patients, and 2 patients had grade 3 serious AEs due to treatment with pegulicianine.

“During lumpectomy surgery, surgeons still struggle to identify and remove all of the tumor during the first operation,” said Barbara Smith, MD, PhD, director of the breast program at Massachusetts General Hospital and professor of surgery at Harvard Medical School, in a press release.1 “With LumiSystem, we will now have a technology that is clinically proven to achieve a more complete cancer resection during lumpectomy that could help some patients avoid a second surgery.”

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://tinyurl.com/3s86tbvs
  2. 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
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