Bayer HealthCare announced that the FDA has approved a new indication for Gadavist (gadobutrol) injection for IV use with MRI of the breast to assess the presence and extent of malignant breast disease.

The FDA approval is based on priority review of two Phase 3, multi-center studies (GEMMA-1 and GEMMA-2) that investigated the diagnostic efficacy of Gadavist-enhanced breast MRI. Gadavist-enhanced breast MRI showed superior sensitivity (range: 80–89%) for the presence and extent of malignant disease vs. unenhanced breast MRI (range: 37–73%) for all six readers. A specificity of >80% for breasts without malignant disease was confirmed for Gadavist-enhanced breast MRI by 5 of 6 readers.

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Gadavist was first approved in March 2011 for IV use in diagnostic MRI in patients >2 years to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

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