The US Food and Drug Administration (FDA) has approved Bayer HealthCare’s Gadavist (gadobutrol) injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the US.
The agency has approved the new indication for Gadavist injection for intravenous use with magnetic resonance imaging of the breast to assess the presence and extent of malignant breast disease.
Approval is based on priority review of two Phase III studies with identical design (GEMMA-1 and GEMMA-2).
GEMMA principal investigator Dr Gillian Newstead said: "The Phase III 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.
"Breast MRI with Gadavist provides important visibility for assessment of malignant breast disease and for treatment planning."
Diagnostic efficacy of Gadavist-enhanced breast MRI was evaluated in the GEMMA-1 and GEMMA-2 studies.
In these two multi-centre Phase III trials, a total of 787 patients (GEMMA-1: 390 women; GEMMA-2: 396 women and one man) with recently diagnosed breast cancer from 13 countries were enrolled.
In each study, three independent radiologists analysed the MRI images and confirmed that Gadavist-enhanced breast MRI improved ability to assess the presence and extent of breast cancer when compared with images from unenhanced breast MRI.
Reading X-ray mammography alone, three additional radiologists found that, over both studies, sensitivity for the presence and extent of malignancy ranged from 68%-73% and specificity ranged from 86%-94% in non-malignant breasts in each study.
Gadavist injection was first approved in the US in March 2011 for intravenous use in diagnostic MRI in adults and children (two years of age and older) to detect and visualise areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.