FDA Approves New Contrast Agent for Imaging of Tumors in Adults with Known Hepatocellular Carcinoma

An ethiodized oil contrast agent was approved by the US Food and Drug Administration (FDA) for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC).

HCC is the most common primary liver tumor and represents the third-leading cause of cancer-related death in the world, with prevalence in United States estimated to affect in the range of 35,000 US patients in 2013.

Discovered in 1901 by Marcel Guerbet, Lipiodol is approved for use in over 47 countries in Europe, Asia, Africa, Middle East, and North and South America. Lipiodol is the first and only oil-based iodinated contrast medium for imaging.

Guerbet (Roissy, France), a developer of contrast agents for medical imaging, reported that Lipiodol has received an orphan-drug designation for management of patients with known HCC. “Guerbet is pleased to have been granted approval for use of Lipiodol in patients with known HCC. This product has been supplied during the past three years under a temporary importation program. Guerbet’s efforts to improve the availability of Lipiodol in the USA are in line with our company mission offering reliable and innovative solutions to improve the efficacy of interventional radiology procedures,” commented Massimo Carrara, Guerbet US general manager.

“The additional indication approved by FDA is a major milestone on the ambitious approach taken by the company to keep the product accessible for US patients to assist in the management of this devastating disease. We are pleased to receive FDA authorization, which assures continuous accessibility to this drug to many HCC patients across America,” said Corina Harper, Guerbet director of North America Medical and Regulatory Affairs.

Guerbet plans to transition from the temporary importation program as soon as product from the newly approved manufacturing plant will be available in the United States.

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