The FDA has given Bayer’s Gadavist approval for use with MRI of the breast to evaluate malignant breast disease.
The United States Food and Drug Administration (FDA) has approved Gadavist (gadobutrol), the first MR contrast agent for evaluation of breast cancer approved in the United States, Bayer announced in a release.
The new indication for Gadavist, an injection for intravenous use, is with MRI of the breast to assess the presence and extent of malignant breast disease. Gadavist’s original indication, which was approved in the U.S. in March 2011, was for intravenous use in diagnostic MRI in adults and children (2 years and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system, Bayer said in the release.
The approval of Gadavist for breast cancer evaluation comes after priority review of two multi-center Phase 3 studies (GEMMA-1 and GEMMA-2), which were conducted in 13 countries.
The studies show that Gadavist-enhanced breast MRI provided a statistically significant improvement in the identification of the extent of breast cancer versus unenhanced MRI, Gillian Newstead, MD, FACR, GEMMA principal investigator, said in the release.
The trials included 787 patients with recently diagnosed breast cancer. MRI images were analyzed by three independent radiologists in each study. All six readers found Gadavist-enhanced breast MRI to demonstrate superior sensitivity (80–89 percent) for the presence and extent of malignant disease compared to unenhanced breast MRI (37–73 percent), according to the release. Five of six of the readers confirmed a specificity of >80 percent for breasts without malignant disease for Gadavist-enhanced breast MRI, the release stated. The release also noted that 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 patients.
“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,” Dennis Durmis, head of the Americas Region for Bayer’s Radiology & Interventional business, said in the release.
“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,” Newstead said in the release.