The FDA has approved a new indication for Bayer Healthcare’s 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 III studies (GEMMA-1 and GEMMA-2) conducted in 13 countries.

In total, 787 patients with recently diagnosed breast cancer from 13 countries were enrolled (GEMMA-1: 390 women; GEMMA-2: 396 women and one man).  In each study, MRI images were analyzed by three independent radiologists. These readers confirmed that Gadavist-enhanced breast MRI improved ability to assess the presence and extent of breast cancer when compared to images from unenhanced breast MRI.

"The phase III 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 U.S. 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."