The Massachusetts-based biotech Lumicell won FDA approval on Thursday for its drug-device combination product used to help detect residual cancer in breast cancer patients, the FDA announced.
The combo of both the optical imaging agent pegulicianine and the company’s Direct Visualization System or another fluorescence imaging device allows surgeons to scan for and remove residual cancer that may otherwise go undetected.
“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,” Lumicell President Howard Hechler said in a press release.
The drug, marketed as LumiSight, is injected into the veins ahead of surgery to help surgeons identify where residual cancer is located using the imaging device. Once identified, the surgeon can then remove the tissue.
The drug component was granted approval via a new drug application, and the device portion was granted pre-market approval. The product received priority review and was cleared via the FDA’s fast track program.
The device is meant for after lumpectomy surgery, which can remove cancerous lumps from the breast, with the goal of saving patients from having to undergo a second surgery.
Kelly Hunt, chair of the Department of Breast Surgical Oncology at MD Anderson, underscored in the release that it’s currently challenging for surgeons to carry out a complete tumor recession in breast cancer patients, and up to a third of patients end up needing a second surgery.
Out of a total of 357 breast cancer patients who underwent surgery using LumiSystem, 27 were identified as having residual cancer. The study also evaluated the system’s ability to detect imaged areas with disease as positive, or sensitivity, and those without as negative, or specificity. Sensitivity came out at about 49% and specificity was about 86%.
The FDA flagged a risk for false negative and false positive findings leading to misdiagnosis. In the trial, 43% of patients had at least one false negative image and 8% of patients had at least one false positive image.
The most common side effects reported included hypersensitivity and abnormal color in urine.