FDA approves Gadavist for breast cancer evaluation

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The FDA has approved Bayer HealthCare’s Gadavist (gadobutrol) as the first intravenous MR contrast agent for evaluation of breast cancer in the U.S.

The approval is based on a priority review of a pair of Phase 3 trials, GEMMA-1 and GEMMA-2. Combined, the studies looked at 787 patients recently diagnosed with breast cancer from 13 countries and found Gadavist-enhanced breast MRI improved the ability of readers to assess the presence of breast cancer. Sensitivity for Gadavist-enhanced breast MRI in detecting malignant disease ranged from 80 to 89 percent, while sensitivity for unenhanced MRI ranged from 37 to 73 percent. Specificity of greater than 80 percent was reported for Gadavist-enhanced breast MRIs by five of the six readers involved in the studies.

The studies also indicated that in breasts with malignancy, Gadavist-enhanced breast MRI overestimated the histologically confirmed extent of malignancy in up to half of patients.