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FDA approves indication for Gadavist as MRI contrast agent
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The FDA today approved gadobutrol injection for intravenous use as a magnetic resonance contrast agent during breast cancer evaluations.
The approval for the expanded use of gadobutrol (Gadavist, Bayer HealthCare) was based in part on two phase 3 studies — GEMMA-1 and GEMMA-2 — which included 787 total patients with newly diagnosed breast cancer.
According to study results, the sensitivity for presence or extent of malignancy associated with gadobutrol-enhanced breast MRI ranged from 80% to 89%, which was superior to the 37% to 73% sensitivity associated with unenhanced breast MRI.
Researchers also observed greater than 80% specificity in the enhanced MRIs of patients with breast cancer without malignant disease. However, gadobutrol-enhanced breast MRIs were associated with up to 50% overestimations of the extent of histologically confirmed malignancy.
Gillian Newstead
Researchers then compared these results with X-ray mammography. Sensitivity associated with X-ray mammography for the presence or extent of malignancy ranged from 68% to 73%, and specificity ranged from 86% to 94% in patients without malignancies.
“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 vs. unenhanced MRI,” study investigator Gillian Newstead, MD, FACR, from the University of Chicago Medical Center, said in the press 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.”
The most frequent adverse reactions associated with gadobutrol were headache (1.5%), nausea (1.2%), injection site reaction (0.6%), dysgeusia (0.5%) and feeling hot (0.5%).
Gadobutrol first received FDA approval in 2011 as an MRI contrast agent to detect disrupted blood brain barrier and/or abnormal central nervous system vascularity.