News Feature | April 11, 2014

Lipiodol Injection Receives FDA Approval For HCC Tumor Imaging

By Estel Grace Masangkay

The U.S. Food and Drug Administration (FDA) has approved Lipiodol (ethiodized oil) injection for brain tumor imaging in adult patients with known hepatocellular carcinoma (HCC). Lipiodol is manufactured by Guerbet, a pharmaceutical group focusing on the field of contrast agents for medical imaging.

Lipiodol is the first and only oil-based iodinated contrast agent for radiology, available by prescription only. The contrast agent is approved for use in more than 47 countries around the world. Guerbet acquired the NDA for Lipiodol from Nycomed in 2010.

Massimo Carrara, Guerbet US General Manager, said, “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.”

Hepatocellular carcinoma is the most common type of primary liver tumor, affecting an estimated range of 35,000 patients in the U.S. in 2013. HCC represents the third leading cause of death worldwide due to cancer.

Corina Harper, Guerbet Director of North America Medical and Regulatory Affairs, said, “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.”

The FDA approved Lipiodol in accordance to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act indicated for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC). Lipiodol has also been granted an Orphan Drug designation for management of patients with known HCC.