Woman examining her breasts for cancer
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In a potentially dramatic advance for breast cancer patients, there is now a much better tool for surgeons to tell if they have gotten “all” the cancer out during a lumpectomy.

The FDA has approved the LUMISIGHT (pegulicianine) optical imaging agent and the Lumicell Direct Visualization System (DVS), together referred to as LumiSystem. With 84% diagnostic accuracy, LumiSystem lets surgeons scan the breast cavity post-lumpectomy, in real-time, to detect and resect residual cancer that may have otherwise been missed, potentially sparing some patients second surgeries.  

“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. “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.” 

The LumiSystem is indicated for adults with breast cancer as an adjunct for intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. Results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial, used to support the efficacy of the system, were published in NEJM Evidence

“Breast cancer is all too common, and sadly, 1 in 8 women will develop it during their lifetime,” said Kelly Hunt, MD, chair of the department of breast surgical oncology at MD Anderson Cancer Center and president of the Society of Surgical Oncology.  

She added, “Our most common surgical procedure to treat these women is lumpectomy. Unfortunately, the intraoperative tools we have are limited and do not identify the extent of tumor accurately enough, making it challenging to achieve a complete tumor resection, leading to as many as 36% of patients needing a second surgery.”

“Up to 65% of the time, we do not find residual cancer in the second surgery and are left wondering if we performed an unnecessary surgery due to a false positive margin assessment or if the cancer was missed again in the second surgery,” said Irene Wapnir, MD, breast surgical oncologist and professor of surgery, Stanford University School of Medicine.

The safety of the system was established using data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers across the United States. The most common side effects with LUMISIGHT are hypersensitivity and an abnormal color in urine, and it may also cause serious hypersensitivity reactions, including anaphylaxis.  

“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,” said Howard Hechler, president and COO, Lumicell. 

He added, “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.”


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