Bayer's gadavist injection gets FDA approval as MRI contrast agent

Bayer's gadavist injection gets FDA approval as MRI contrast agent

Bayer HealthCare has received approval from the US Food and Drug Administration (FDA) for a new indication for Gadavist (gadobutrol) injection for intravenous use with MRI of the breast to assess the presence and extent of malignant breast disease.

The FDA approval is based on priority review of two, multi-center, Phase III studies GEMMA-1 and GEMMA-2 carried out in 13 countries.

The GEMMA principal investigator Gillian Newsteads said the Phase III GEMMA studies show that Gadavist-enhanced breast MRI provided a statistically significant improvement in the identification of the extent of breast cancer versus unenhanced MRI.

"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," Newsteads said.

Bayer HealthCare head of Global Innovation for Medical Care Christiane Pering said recognizing an unmet medical need, the FDA's priority review and swift action provides access to an advancement in breast cancer management in the US.

"The GEMMA studies demonstrate Bayer's commitment to improve breast cancer detection - the leading cause of cancer-related deaths among women worldwide - through radiologic advances such as Gadavist-enhanced breast MRI," Pering said.

The two, multi-center, Phase III trials with identical design (GEMMA-1 and GEMMA-2) were used to investigate the diagnostic efficacy of Gadavist-enhanced breast MRI.

In total, 787 patients with recently diagnosed breast cancer from 13 countries were enrolled in these trials.