Bayer HealthCare announced today that the FDA has approved a new indication for Gadavist (gadobutrol) injection for intravenous use with MRI of the breast to assess the presence and extent of malignant breast disease. The approval is based on priority review of two, multi-center, Phase 3 studies (GEMMA-1 and GEMMA-2) conducted in 13 countries.
"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," said GEMMA Principal Investigator Gillian Newstead, M.D., F.A.C.R., from the University of Chicago Medical Center. "This is an important diagnostic tool for healthcare professionals with breast cancer patients. Breast MRI with Gadavist provides important visibility for assessment of malignant breast disease and for treatment planning." "While we've made great strides in the US with early detection, one in five women will still have undetected breast cancer following a mammogram," said Dennis Durmis, Head of the Americas Region for Bayer's Radiology & Interventional business. "The FDA's swift action in approving Gadavist for contrast enhanced breast MRI is consistent with recent guidelines from cancer and breast imaging societies."