Transarterial Chemoembolization Contrast Agent Approved by French National Agency for Liver Cancer

An imaging agent has been recently approved by the French National Agency for Medicines and Health Products (ANSM) for selective hepatic intra-arterial injection for visualization, localization, and vectorization during chemoembolization of tumors in adults with known, intermediate-stage hepatocellular carcinoma (HCC).

According to the World Health Organization (WHO; Geneva, Switzerland), HCC is the most common primary cancer and is the second biggest cause of death due to cancer worldwide.

“Guerbet [GBT; Villepinte, France] enters a new phase in obtaining this indication for Lipiodol in France for conventional transarterial chemoembolization [cTACE]. This procedure is carried out to deposit, in contact with the tumor, active substances which fight against the development of primary cancers in inoperable patients. The development of these minimally invasive, image-guided procedures is the new priority of Guerbet’s interventional radiology and theranostic division to enhance patient prognosis and quality of life,” commented Yves L’Epine, Guerbet’s CEO.

This approval follows that granted by the Japanese authorities in November 2013 for the treatment by conventional transarterial chemoembolization of HCC2 and the one granted by US authorities in April 2014 for the imaging of HCC3.

Worldwide, over 100 clinical studies have been published, including 12 randomized clinical trials on a total of over 10,000 patients presenting with an intermediate stage HCC. Recently, three international recommendations in Europe, the United States, and Japan established cTACE as the reference treatment for patients presenting with an intermediate-stage HCC. These consensual recommendations unanimously accredited the use of cTACE as the benchmark treatment for patients with known intermediate stage HCC. The recommendations reported that the life expectancy of inoperable HCC patients is increased, on average, by 16 to 20 months, due to cTACE. In recent clinical trials, using the most selective catheterization techniques, life expectancy was improved to 45 months. Consequently, treatment by cTACE use is constantly increasing on all continents, with an extra 500,000 patients being treated yearly.

Traditional cTACE is a minimally invasive procedure that consists of integrating Lipiodol Ultra-Fluid with an anticancer agent and injecting this mixture in the liver transarterially by targeted regional chemotherapy. Lipiodol Ultra-Fluid acts as a contrast agent, an eluent for cancer drugs, and a transient vascular embolization agent. cTACE was performed for the first time in Japan in 1982 and has since been successfully used in Asia, Europe, in the Middle East, Africa, and North America.

Lipiodol Ultra-Fluid (ethyl esters of iodized fatty acids of poppyseed oil) was originally developed for diagnostic radiology including the diagnosis of hepatic lesions, lymphography, and hysterosalpingography. Subsequently, the agent was used in interventional radiology for the treatment using standard cTACE of multinodular hepatocellular carcinoma, in which Lipiodol Ultra-Fluid is used as for its properties a contrast agent, vehicle for active substances, and embolization agent.

Guerbet is a pharmaceutical group fully focused on medical imaging worldwide. The company has a range of contrast agents for X-ray and magnetic resonance imaging (MRI) and for interventional radiology, along with a range of injectors and related medical equipment to provide improved diagnosis and treatment of patients.

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