Bayer’s Gadavist Gains FDA Approval for New Indication

Bayer HealthCare announced it received FDA approval for a new indication for its Gadavist (gadobutrol) injection for intravenous use with a MRI of the breast to evaluate the presence and extent of malignant breast cancer.

The German drugmaker said approval is based on the review of two identically designed, multi-center, Phase III GEMMA studies of 787 patients, carried out in 13 countries.

In each study, MRI images were analyzed by three independent radiologists. They confimed that Gadavist-enhanced breast MRI improved ability to assess the presence and extent of breast cancer when compared to images from unenhanced breast MRI, the company added.

MRI that used Gadavist demonstrated superior sensitivity—a range of 80 to 89 percent— for the occurrence and extent of malignant disease compared to a range of 37 to 73 percent for MRI without Gadavist. When using x-ray mammography, the range was from 68 to 73 percent, the company said.

The principal investigator of the trails, Gillian Newsteads, said the studies confirmed that “Breast MRI with Gadavist provides important visibility for assessment of malignant breast disease and for treatment planning.”

The prior indication for the gadolinium-based contrast agent was for use in regular MRI scans of the brain, spine and other body parts. — Kellen Owings

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