Gadobutrol (Gadavist) injection for intravenous use with breast MRI to detect and identify the extent of disease.
The approval is based on phase III GEMMA-1 and GEMMA-2 trials, which demonstrated a statistically significant improvement in the detection and identification of extent of disease of breast cancer with a 80-89% sensitivity, compared with unenhanced MRI at 37-73%.
Breast MRI with gadobutrol provides an assessment of breast cancer, and for treatment planning.
Has a true-negative rate of greater than 80% for breasts without malignant disease for gadobutrol-enhanced MRI.
In breasts with malignancy, gadobutrol-enhanced MRI overestimates histologically confirmed extent of disease in up to 50% of patients.
Sensitivity for the presence and extent of breast malignancy is 68-73% and specificity of 86-94% in non-malignant breasts.
Approved to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system (CNS) in adults and children over two years old.
Patients may experience somnolence, headache, nausea, dizziness, diarrhea, and fatigue.