Bayer’s iodine-based contrast agent Ultravist-300, -370 is now approved for contrast-enhanced mammography (CEM) in the EU. The product can be used to evaluate and detect lesions of the breast as an adjunct to mammography (with or without ultrasound) or as an alternative when a magnetic resonance imaging (MRI) is contraindicated or unavailable.

Following the approval of the European Workshare Procedure (a decentralized mutual recognition process on EU level), the first national approvals in the EU are expected in the first quarter of 2023. CEM is an emerging modality that combines digital mammography with the administration of a contrast agent, such as Ultravist, to support the diagnosis of breast cancer and guide treatment decisions. The approval expands Bayer’s radiology portfolio, which includes contrast media, injectors as well as digital and artificial intelligence (AI) enabled solutions, supporting radiologists across a broad range of diseases including breast cancer.

“Early detection of cancer can save lives. Imaging options such as contrast-enhanced mammography can help improve diagnostic accuracy, potentially identifying cancers that otherwise might have been missed, said Dr Julia Camps Herrero, Corporate Chief of Breast Health, Ribera Salud Hospitals Spain.

Dr Konstanze Diefenbach, Head of Radiology Research and Development, Bayer, noted: “The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough. 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 direction from diagnosis to care for patients.”

Breast cancer treatment can be very effective, especially when the disease is identified early. CEM is a highly sensitive and relatively low-cost breast imaging examination, with an increasing number of independent scientific publications affirming its value as an adjunct to mammography. It is easy to perform in everyday clinical practice and can be used in various clinical settings, such as inconclusive findings in previous imaging procedures, or preoperative assessment of the extent of the disease. It can also be a helpful tool when MRI is unavailable or contraindicated.

Ultravist is an iodine-based contrast medium for X-ray techniques requiring contrast enhancement such as conventional radiography, angiography and computed tomography. Available in more than 100 countries, Ultravist is currently being applied more than 18 million times a year. Depending on the country, Ultravist is approved for use across a vast range of indications such as CT of the head, chest, heart, abdomen, and liver; multi-detector CT for stroke/ischemic damage and imaging of the abdominal viscera; CT angiography of vessels in the head, heart and peripheral parts of the body; conventional radiology for duct systems/body cavities and urography; contrast enhancement of body cavities, e.g., arthrography; and paediatric imaging, including in very young children.

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