FDA Approves Pegulicianine-Based Imaging for Breast Cancer Surgery


Results from the INSITE trial support the utility of pegulicianine fluorescence-guided surgery during breast cancer surgery.

Data from the phase 3 INSITE trial (NCT03686215) supported the efficacy of pegulicianine-based imaging in patients undergoing surgery for breast cancer.

Data from the phase 3 INSITE trial (NCT03686215) supported the efficacy of pegulicianine-based imaging in patients undergoing surgery for breast cancer.

The FDA has approved the optical imaging agent pegulicianine (Lumisight) and the LumicellTM Direct Visualization System (DVS)—collectively referred to as LumiSystemTM—for fluorescence-based imaging in adult patients undergoing surgery for breast cancer, according to a press release from developers Lumicell, Inc.1

Specifically, the LumiSystem combination is indicated for use as an adjunct for intraoperatively detecting cancerous tissue in the resection cavity after the primary specimen is removed during lumpectomy surgery. This practice may help spare a second surgery.

Data from the phase 3 INSITE trial (NCT03686215) backed the system’s efficacy in this population.

According to findings published in NEJM Evidence, the margin-level specificity of pegulicianine fluorescence-guided surgery for breast cancer was 85.2% (95% CI, 83.7%-86.6%) among 406 patients.2 Additionally, investigators reported a sensitivity level of 49.3% (95% CI, 37.0%-61.6%).

Regarding safety, 1.5% (n = 6) of patients stopped receiving pegulicianine due to adverse effects (AEs). Grade 3 serious AEs related to pegulicianine affected 0.5% (n = 2) of patients, which included hypersensitivity in 1 patient and an anaphylactic reaction in another. Investigators highlighted that all toxicities were resolved and that patients were able to proceed with their scheduled lumpectomy.

“Tools like [pegulicianine] that let you look at the entire cavity, instead of less than 1%, to find residual tumor is just game-changing,” Barbara Smith, MD, PhD, director of the Breast Program at Massachusetts General Hospital and a professor of surgery at Harvard Medical School, said in an interview with CancerNetwork® during the Society of Surgical Oncology (SSO) 2024 Annual Meeting.

“The idea that you’re removing more tumor is going to also potentially let us deescalate other treatments that patients [must] have right now. Right now, in lumpectomy surgery, almost everyone [must] have radiation afterward because we know we’re leaving a tumor behind; we had no way to find it. It may be that you can have patients have lesser treatments from other modalities than they do now because we’re able to do a better job surgically,” Smith added.

In the prospective INSITE trial, 406 patients were assigned to receive 1.0 mg/kg of pegulicianine intravenously followed by lumpectomy. The trial’s coprimary end points included the percentage of patients with cancer left behind in pegulicianine-guided surgical margins as well as the sensitivity and specificity of pegulicianine-guided surgery. Secondary end points included the positive margin rate of pegulicianine-guided margins and the impact of pegulicianine-guided margins on the volume of tissue excised.

Patients 18 years and older undergoing lumpectomy for stages I to III invasive breast cancer and/or ductal carcinoma in situ were eligible for enrollment on the trial. Those who were treated with neoadjuvant therapy or undergoing margin re-excision following previous lumpectomy were ineligible for enrollment.

“We are immensely proud of the dual approval of [pegulicianine] 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 new drug application [NDA] and premarket approval application [PMA] review processes,” Howard Hechler, president and chief operating officer at Lumicell, said in the press release.1 “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.”

The FDA granted priority review to the NDA for pegulicianine as an imaging agent during breast cancer surgery in May 2023.3 Additionally, the agency accepted the PMA for the Lumicell DVS at the time.

The FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) voted in support of pegulicianine-based imaging for this population in March 2024.4 The MIDAC had cast a 16-to-2 vote supporting the use of pegulicianine-guided surgery in combination with the Lumicell DVS.


  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/yc7t26f2
  2. Smith BL, Hunt KK, Carr D, et al. Intraoperative fluorescence guidance for breast cancer lumpectomy surgery. NEJM Evid. 2023;2(7). doi:10.1056/EVIDoa2200333
  3. Lumicell announces FDA acceptance and priority review of new drug application for LUMISIGHT™ optical imaging agent for breast cancer. News release. Lumicell. May 22, 2023. Accessed April 18, 2024. https://yhoo.it/41YidAT
  4. 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 April 18, 2024. https://tinyurl.com/mucd64en
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