Bayer gets Ultravist FDA approval for contrast-enhanced mammography

Bayer has received US Food and Drug Administration (FDA) approval for Ultravist (iopromide) injection, its iodine-based contrast agent, to be used for contrast-enhanced mammography (CEM).

This marks Ultravist as the sole contrast agent approved for this purpose. The product will be employed to enhance visualization of known or suspected breast lesions in adult patients, complementing mammography and/or ultrasound procedures.

This FDA approval aligns with the growing emphasis on supplemental imaging requirements for women at an elevated risk for breast cancer, including potentially 40-50% of American women aged over 40 with dense breasts. The use of contrast-enhanced mammography, which pairs digital mammography with a contrast agent like Ultravist, can improve the identification of breast lesions.

Dr Konstanze Diefenbach — Bayer Head of Radiology Research and Development said: “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 answers from diagnosis to care for patients.”

Bayer’s commitment to breast imaging is further underscored by this approval. The company’s portfolio already includes Gadavist, a gadolinium-based contrast agent sanctioned for use with Magnetic Resonance Imaging (MRI) to evaluate the presence and extent of malignant breast disease in adult patients.

In 2019, the US also cleared the MEDRAD Stellant FLEX Computed Tomography (CT) Injection System with Certegra Workstation for use in CEM. By using iodine-based x-ray contrast agents, contrast-enhanced mammography could enhance the visualization of abnormalities in breast tissue that might not be identifiable with standard mammography.