FDA Accepts Priority Review of Pegulicianine Imaging Agent for Residual Breast Cancer


The imaging agent and visualization system will be an adjunct to standard of care to reduce residual cancer in the lumpectomy cavity during initial surgery.

The FDA accepted and granted priority review designation to pegulicianine (Lumisight Optical Imaging Agent; Lumicell) following a new drug application (NDA); the FDA also accepted the premarket approval (PMA) application for the Lumicell Direct Visualization System (DVS), according to a recent press release.

If the system is FDA-approved, it will be the only optical imaging agent and device solution that can assess the lumpectomy cavity in real time, hopefully improving outcomes and creating a more complete cancer resection.

"The FDA acceptances of both the NDA and PMA submissions for our [pegulicianine imaging agent] and Lumicell [DVS] bring us one step closer to advancing care for women with breast cancer,” said Kevin Hershberger, president and chief executive officer of Lumicell, in the press release. “Priority Review designation is further recognition of the potential of our system to significantly improve the effectiveness of breast cancer treatment.”

Lumicell DVS is an investigational system that was designed to help detect residual malignant tissue within the lumpectomy cavity after the primary tumor was removed during breast conserving surgery. This hand-held imaging probe that uses patient-calibrated cancer detection software enables more complete cancer resection when used with peguliacianane. The system is designed to be an adjunct to standard of care (SoC) treatment.

The FDA based their decision to grant priority review designation for pegulicianine based on the results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) trial. INSITE included 5 clinical studies with 700 patients with breast cancer, the results of which were published in NEJM Evidence and JAMA Surgery.

As a result of SoC lumpectomy surgery, 20% to 40% of lumpectomies have residual cancer (positive margins) within days of surgery; patients often require a second surgery to remove the residual cancer. In addition, current literature suggests that approximately 14% of patients who have surgery and are informed by the pathologist that there is no residual cancer inside the lumpectomy cavity have residual cancer.

Previously, FDA granted pegulicianine Fast Track designation and Lumicell DVS was granted Breakthrough Device designation because they may provide important benefits in identifying residual cancer during initial lumpectomy. However, Lumicell DVS and pegulicianine are only available for investigational use and are not yet commercially available. Future approval of this system could lead to better detection of residual cancer so it can be removed during initial surgery for a more complete cancer resection.

“We look forward to the FDA's review of our applications, and the potential to offer surgeons the first visualization system to enable a more complete cancer resection during the initial lumpectomy,” Hershberger said in the press release.


Lumicell, Inc. Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for LUMISIGHT™ Optical Imaging Agent for Breast Cancer. News Release. May 22, 2023. Accessed on May 23, 2023. https://www.businesswire.com/news/home/20230522005109/en

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