FDA votes in support of benefit-risk profile for Lumisight imaging agent
The U.S. Food and Drug Administration (FDA) voted in support of the benefit-risk profile of Lumisight (pegulicianine), an imaging enhancement agent used with the Lumicell fluorescent-guided imaging system. The combination is used to identify and provide details on residual breast cancer cells in real-time for more effective lumpectomy surgeries.
In a 16 to 2 vote, the Medical Imaging Drugs Advisory Committee (MIDAC) agreed that the benefits of the imaging agent outweigh the risks, based on an independent review of the efficacy of Lumisight. One member of the committee abstained from voting.
The decision was made in part because of a study on 350 patients that measured the efficacy of Lumisight in conjunction with the Lumicell system, along with six clinical trials on more than 700 patients that showed the drug is relatively safe and well tolerated. The research was conducted by Lumicell in cooperation with the National Cancer Institute, and the findings were published on ClinicalTrials.gov.
“This MIDAC vote, supported by more than 10 years of clinical evidence, is an exciting further validation of our work,” Jorge Ferrer, chief scientific officer at Lumicell said in a statement.
Lumicell is still awaiting a decision from the FDA on its new drug application for premarket approval for Lumisight. After the MIDAC vote, approval for commercial use of the fluorescent imaging with the drug is expected in the near future.
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