Guerbet has announced the approval of an additional indication for Lipiodol Ultra-Fluid by the China NMPA (National Medical Products Administration) for use in transarterial chemoembolization (cTACE) for hepatocellular carcinoma (HCC) at intermediate-stage in adult patients in the People’s Republic of China.
HCC is the most common primary liver cancer and the fourth biggest cause of death due to cancer worldwide. China alone represents more than 50% of all primary liver cancers globally since the country has the highest liver cancer prevalence in the world according to the WHO with about 330 000 cases.
“Guerbet is honoured to receive the NMPA approval for this indication for Lipiodol Ultra-Fluid in China. This registration reflects a strong positive endorsement from Chinese interventional oncologists and provides them with an additional NMPA endorsed therapy for managing patients with HCC in China. This is also evidence of our commitment to making cTACE available to as many HCC patients as possible.” commented David Hale, Guerbet’s CEO. “Development of image-guided procedures is a top priority for Guerbet’s Interventional Imaging Business Unit as we work to enhance liver cancer patients’ prognosis and quality of life in China and worldwide.”
Lipiodol Ultra-Fluid is used in interventional oncology for conventional transarterial chemoembolization, a minimally invasive procedure which consists of mixing Lipiodol Ultra-Fluid with an anticancer drug. The mixture is injected trans-arterially in the liver as a locoregional targeted chemotherapy for unresectable liver tumors (HCC). Lipiodol UltraFluid acts as a contrast agent, a drug vehicle, and a dual arterioportal transient embolic.
For interventional oncology procedures, Lipiodol Ultra-Fluid is approved for cTACE indication in EMEA (Austria, Belgium, Czech Republic, Denmark, France, Hungary, Iran, Ireland, Luxembourg, Portugal, Switzerland, the Netherlands, Tunisia, Turkey), in the Americas (Argentina, Colombia, Brazil, Chile, Mexico, Peru, Uruguay) and in Asia-Pacific (Australia, Brunei Darussalam, Cambodia, Hong Kong, India, Mongolia, New Zealand, Philippines, South Korea, Sri Lanka, Taiwan, Thailand, Vietnam).
Lipiodol Ultra-Fluid is approved for Imaging of patients with known HCC in the USA, in Canada and in Germany. Lipiodol Ultra-Fluid is approved for adjustment of Epirubicin hydrochloride for transarterial injection in Japan.