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The U.S. Food and Drug Administration has approved Gadavist (gadobutrol) injection for intravenous use with magnetic resonance imaging of the breast to assess the presence and extent of malignant breast disease.

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"The Phase 3 GEMMA studies demonstrate that Gadavist-enhanced breast MRI provided a statistically significant improvement in the identification of the extent of breast cancer versus unenhanced MRI," principal investigator Gillian Newstead, MD, FACR, Clinical Director for the Section of Breast Imaging at the University of Chicago Medical Center, said in a news release.


The approval is based on priority review of two, identically designed, multicenter, Phase III studies (GEMMA-1 and GEMMA-2) conducted in 13 countries, which enrolled 787 patients with recently diagnosed breast cancer.


MRI images were analyzed by three independent radiologists who confirmed that Gadavist enhanced breast MRI-improved ability to assess the presence and extent of breast cancer when compared with images from unenhanced breast MRI. Gadavist-enhanced breast MRI demonstrated superior sensitivity (80% to 89%) to detect the presence and extent of malignant disease compared with unenhanced breast MRI (37% to 73%).


Gadavist, made by Bayer HealthCare, was first approved in the U.S. in 2011 for intravenous use in diagnostic MRI in adults and children (age two and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.