FDA Approves Gadavist (Gadobutrol) Injection as First Contrast Agent for Breast MRI in United States

June 20, 2014 — Bayer HealthCare announced the U.S. Food and Drug Administration (FDA) approved a new indication for Gadavist (gadobutrol) injection for intravenous use with magnetic resonance imaging (MRI) of the breast to assess the presence and extent of malignant breast disease. The approval is based on priority review of two multicenter, Phase III 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., FACR, 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 United States 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 and 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."

The GEMMA studies were used to investigate the diagnostic efficacy of Gadavist-enhanced breast MRI. 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.

Key findings for these studies included:

• Gadavist-enhanced breast MRI demonstrated superior sensitivity (range: 80-89 percent) for the presence and extent of malignant disease compared to unenhanced breast MRI (range: 37-73 percent) for all six readers.

• A true-negative rate (specificity) of >80 percent for breasts without malignant disease was confirmed for Gadavist-enhanced breast MRI by 5 of 6 readers.

The studies did reveal that in breasts with malignancy, Gadavist-enhanced breast MRI overestimated the histologically confirmed extent of malignancy in the diseased breast in up to 50 percent of the patients.

Three additional radiologists in each study read X-ray mammography alone. For these readers, over both studies, sensitivity for the presence and extent of malignancy ranged from 68 to 73 percent and specificity ranged from 86 to 94 percent in non-malignant breasts.

Final study findings will be presented at an upcoming medical meeting.

For more information: www.healthcare.bayer.com

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