FDA approves Bayer’s Ultravist (iopromide) Injection for Contrast-enhanced Mammography

June 26, 2023 — Bayer announced that Ultravist (iopromide)-300, -370, its iodine-based contrast agent, has been approved by the U.S. Food and Drug Administration (FDA) for contrast-enhanced mammography(CEM) – making it the only contrast agent approved for this indication. The product can be used to visualize known or suspected lesions of the breast in adults, as an adjunct to mammography and/or ultrasound. CEM is an emerging modality that combines digital mammography with the administration of a contrast agent, such as Ultravist, to help identify breast lesions.1 

The new FDA approved indication aligns with the recent increased focus on supplemental imaging needs for women at a higher risk for breast cancer, which may include the 40-50% of U.S. women older than 40 with dense breasts.2 

“The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough,” said Dr. Konstanze Diefenbach, Head of Radiology Research and Development, Bayer. “We are pleased to be able to offer additional options for breast imaging to healthcare professionals, as we aim to support them in their role of providing clear answers from diagnosis to care for patients.” 

The approval expands upon Bayer's focus on breast imaging, with a portfolio that also includes Gadavist (gadobutrol) injection, a gadolinium-based contrast agent approved for use with MRI (Magnetic Resonance Imaging) to assess the presence and extent of malignant breast disease in adult patients. In 2019, the MEDRAD Stellant FLEXComputed Tomography (CT) Injection System with Certegra Workstation was also cleared in the U.S. for use in CEM. Through the use of iodine-based x-ray contrast agents, CEM can allow for better visualization of abnormalities in breast tissue that may not be visible with standard mammography.3 

About breast cancer and contrast-enhanced mammography 

In 2020, there were 2.3 million women diagnosed with breast cancer globally, according to the World Health Organization(WHO).4 Contrast-enhanced mammography (CEM) has been demonstrated to help with visualization of lesions in breast tissue and is a relatively low-cost breast imaging examination. CEM is easy to perform in everyday clinical practice and can be used in various clinical settings, such as when routine imaging produces inconclusive findings. It can also be a helpful tool when breast MRI is unavailable or contraindicated.5 

For more information: www.bayer.com 

References:  

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