German Federal Institute for Drugs and Medical Devices approves new indication for Lipiodol Ultra-Fluid


Guerbet has announced that the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM; The German Federal Institute for Drugs and Medical Devices) has now approved Lipiodol Ultra-Fluid for use after intra-arterial catheterisation of the hepatic artery for the visualisation and localisation of hepatocellular carcinoma in the intermediate stage in adults.

Hepatocellular carcinoma is the most common primary liver cancer and is the second biggest cause of death due to cancer worldwide.

“Guerbet is proud to be granted approval for this new indication for Lipiodol Ultra-Fluid, this reflects a strong positive endorsement from German liver cancer doctors” commented Maximilian Hudl, general manager of Guerbet in Germany. “The additional indication approved by BfArM is a major milestone on the ambitious approach taken by the company to keep the product accessible for German patients to assist in the management of this devastating disease”, he said. This indication is already approved in the USA.

Lipiodol has a high affinity for primary hepatic tumours and optimises visualisation of hepatocellular carcinomas compared to the surrounding liver parenchyma. Lipiodol-associated to radiofrequency ablation allows the successful treatment of small hepatocellular carcinoma. Most of ultrasound-invisible hepatocellular carcinomas, including tumours in unfavourable locations could be successfully treated using this technique, a press release from Guerbet says.