FDA Approves Drug-Device Combo to Detect Residual Cancer After Lumpectomy

The Food and Drug Administration (FDA) has approved Lumisight^™ (pegulicianine) for fluorescence imaging in adults with breast cancer, as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity, following removal of the primary specimen during lumpectomy surgery.

Pegulicianine, an optical imaging agent, produces a fluorescent signal after it gets cleaved by cathepsins and matrix metalloproteases. The levels of these enzymes are higher in and around tumor and tumor-associated cells than normal cells. Lumisight is used with the Lumicell Direct Visualization System (DVS) or another fluorescence imaging device approved for use with pegulicianine in the indicated population.

The approval was supported by data from the randomized, intra-patient controlled INSITE trial (ClinicalTrials.gov Identifier: NCT03686215), which included patients with confirmed invasive breast cancer, ductal carcinoma in situ, or both. Study participants were randomly assigned to receive Lumisight by intravenous injection 2 to 6 hours before imaging with the Lumicell DVS or to a control arm; patients in the control arm were not included in the efficacy analysis. 

A total of 357 patients underwent Lumisight-guided imaging following standard of care lumpectomy. When positive fluorescence signal was detected, the tissue was resected with a cavity shave procedure and the region was reimaged. The study assessed the proportion of patients receiving Lumisight who had residual cancer detected and removed after the standard of care lumpectomy. As tissue samples were collected during the standard of care procedure and during the Lumisight-guided procedure, patients in the treatment arm were able to serve as their own control to evaluate outcomes.

Results showed a total of 27 of 357 patients had residual cancer confirmed by histopathology in at least 1 Lumisight-guided shave (7.6%; 95% CI, 5.0-10.8). Findings also showed image-level sensitivity and specificity of Lumisight for residual breast cancer after completion of lumpectomy (calculated from 2346 evaluable images) were 49.1% (95% CI, 36.4-61.9) and 86.5% (95% CI, 84.5-88.3), respectively. A total of 155 patients had at least 1 false positive image and 28 patients had at least 1 false negative image.

The most common adverse reactions reported were hypersensitivity and chromaturia. Anaphylaxis and other serious hypersensitivity reactions were observed with Lumisight administration in clinical studies. 

The prescribing information also includes warnings and precautions regarding the risk of misdiagnosis. False positive and false negative findings may occur during use of Lumisight to detect residual cancer. Additionally, blue dyes used for sentinel lymph node mapping procedures have been shown to interfere with Lumisight imaging and should be avoided before imaging the lumpectomy cavity in patients receiving Lumisight.

“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,” said Howard Hechler, President and Chief Operating Officer, Lumicell. “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.”