FDA announces acceptance and priority review of NDA for LUMISIGHT imagining agent for breast cancer

Betsy Goodfellow | May 23, 2023 | News story | Research and Development FDA, Lumicell, Oncology, breast cancer, oncology 

Lumicell has announced that the US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for LUMISIGHT, an optical imaging agent, and has accepted the Premarket Approval (PMA) application for the Lumicell Direct Visualization System (DVS).

Lumicell’s DVS is an investigation system developed for use in patients with breast cancer. It is intended to assist in the detection of remaining cancerous tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery. The DVS is planned to be used alongside the LUMISIGHT (pegulicianine) imaging agent for fluorescence imaging of the cavity.

The company’s submissions follow data from over 700 breast cancer patients across five clinical studies at academic and regional community cancer centres. Results from the pivotal INSITE trial were published in NEJM Evidence with phase C study data released in JAMA Surgery.

Kevin Hershberger, president and CEO of Lumicell, commented: “The FDA acceptances of both the NDA and PMA submissions for our LUMISIGHT Optical Imaging Agent and Lumicell DVS bring us one step closer to advancing care for women with breast cancer. Priority Review designation is further recognition of the potential of our system to significantly improve the effectiveness of breast cancer treatment. We look forward to the FDA’s review of our applications, and the potential to offer surgeons the first visualisation system to enable a more complete cancer resection during the initial lumpectomy.”

Betsy Goodfellow

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