The FDA also accepts a premarket approval application for the Lumicell Direct Visualization System in the breast cancer space.
The FDA has accepted and granted priority review to a new drug application (NDA) for optical imaging agent pegulicianine (LUMISIGHT) for patients with breast cancer, according to a press release from developer Lumicell.1
The regulatory organization also accepted a premarket approval (PMA) application for the Lumicell Direct Visualization System (DVS). The DVS and imaging agent are meant to be used in conjunction with one another. The investigational system consists of a handheld probe that is inserted into the breast cavity coupled with a patient-calibrated cancer detection software. The strategy is meant to detect residual disease to allow for a more complete resection.
In particular, the system is intended to be used during breast conserving surgery by detecting residual tumor tissue in the lumpectomy cavity after the primary specimen is excised.
“The FDA acceptances of both the NDA and PMA submissions for [pegulicianine] and Lumicell [DVS] bring us one step closer to advancing care for [patients] with breast cancer,” Kevin Hershberger, president and chief executive officer of Lumicell, said 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.”
The applications are backed by findings from 2 studies. In the phase 3 INSITE trial (NCT03686215), investigators noted that pegulicianine fluorescence-guided surgery met the prespecified thresholds of residual tumor resection, although it missed the threshold for sensitivity.2
A population of 406 patients, including 392 who were randomly assigned, were administered 1.0 mg/kg of intravenous pegulicianine prior to undergoing lumpectomy. Investigators reported that 27 of 357 patients who received pegulicianine fluorescence-guided surgery had removed tumor left behind, including 22 from cavity orientations that were determined to be negative via margin evaluation.
Additionally, 9 of 62 patients with positive margins avoided second surgeries. The specificity was 85.2% and the sensitivity was 49.3%. The study drug was stopped in 6 patients due to adverse effects (AEs), and 2 patients developed grade 3 serious AEs.
In an earlier pilot feasibility phase 2 study (NCT03321929) published in JAMA Surgery, investigators reported that the safety of pegulicianine used in conjunction with breast conserving surgery was comparable with other imaging agents in the space.3 The study included 234 patients.
Patients received 1 mg/kg pegulicianine at a mean of 3.2 hours prior to surgery. Following surgery, pegulicianine fluorescence-guided surgery was used to assess the lumpectomy cavity to aid in the removal of further shave margins.
Pegulicianine yielded a sensitivity rate of 69.4% compared with 38.2% using standard pathology assessment of primary lumpectomy specimen. Moreover, pegulicianine fluorescence-guided surgery had a false negative rate of 23.7%, and the patient level sensitivity was 76.3%. In a population of 32 patients who needed excision of pegulicianine fluorescence-guided surgery–guided shaves, 19% required re-excision.