Lumicell’s Breast Cancer imaging agent LUMISIGHT received a priority review from the FDA

CAR-T Digest - August 2020

May 22, 2023: LUMISIGHT / Breast cancer / Lumicell: FDA granted a priority review

The FDA granted priority review to a new drug application seeking approval of the optical imaging agent Lumisight for use in breast cancer patients
This priority review was based on the positive data from the Phase 3 INSITE study and Phase 2 FEASIBILITY study
FDA also accepted the premarket approval application for Lumicell™ Direct Visualization System
Lumicell DVS is a system designed to detect residual malignant tissue within the lumpectomy cavity after removing the primary tumor during breast-conserving surgery
“The FDA acceptance of both the NDA and PMA submissions for our LUMISIGHT Optical Imaging Agent and Lumicell Direct Visualization System bring us one step closer to advancing care for women with breast cancer,” said Kevin Hershberger, president, and chief executive officer of Lumicell