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Ultravist™-300, -370 receives green light for indication extension for use in contrast-enhanced mammography (CEM) in a European Workshare Procedure  / CEM is emerging modality combining digital mammography with the administration of a contrast agent  / Strategically expands Bayer’s portfolio in breast imaging, including contrast agents and injectors.

Bayer announced on January 23, 2023 that its 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.

“Breast cancer is the most common cancer worldwide, impacting millions of women and their loved ones around the world,” said Dr. Julia Camps Herrero, Corporate Chief of Breast Health, Ribera Salud Hospitals Spain. “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.”

“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 direction from diagnosis to care for patients.”

About breast cancer and contrast-enhanced mammography

In 2020, there were 2.3 million women diagnosed with breast cancer and 685 000 deaths globally, according to the World Health Organization (WHO). 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.

Public health education about early detection and imaging options is a key factor in fighting breast cancer. Bayer is committed to driving information about this important topic. The company recently launched a global digital information hub to help encourage women to take an active role and make informed decisions about their health: