New indication approved for Guerbet’s Lipiodol® Ultra Fluid

Lipiodol® Ultra Fluid now approved for conventional trans-arterial 
chemoembolization of intermediate-stage hepatocellular carcinoma

Villepinte, France - September 11th, 2018 - 06:00pm (CEST) - Guerbet (GBT) announced today that it has been granted approval for a new indication for Lipiodol^® Ultra Fluid in Belgium, Ireland, Portugal, Hong-Kong and the Philippines, for selective hepatic intra-arterial injection for visualization, localization and vectorization during conventional trans-arterial chemoembolization (cTACE) of tumors in adults with known, intermediate-stage hepatocellular carcinoma (HCC).

HCC is the most common primary liver cancer and is the second biggest cause of death due to cancer worldwide ⁽¹⁾.  

Lipiodol^® Ultra Fluid is used for cTACE, 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 loco-regional targeted chemotherapy for unresectable liver tumors (HCC). Lipiodol^® Ultra Fluid acts as a contrast agent, a drug eluting vehicle, and a dual arterio-portal transient embolic ⁽²⁾. 

cTACE and HCC imaging indications are now approved in EMEA (Austria, Belgium, Czech Republic, France, Germany, Hungary, Iran, Ireland, the Netherlands, Portugal, Turkey), APAC (Cambodia, Hong-Kong, Japan, Mongolia, New Zealand, Philippines, South Korea, Taiwan, Thailand, Vietnam), North America (Canada, USA) and Latin America (Argentina, Brazil, Mexico, Peru). Other registrations are ongoing in Asia and in Europe. 

The approval in Belgium, Ireland, Portugal, Hong-Kong and the Philippines testifies to the Guerbet commitment to develop its Interventional Imaging franchise and invest in clinical programs and R&D to deliver enhanced and innovative interventional oncology therapies. 

Guerbet Lipiodol^® Ultra Fluid is used in cTACE procedures to treat patients with unresectable liver tumors. cTACE has been extensively studied worldwide and a systematic review of efficacy on more than 10,000 patients and safety on more than 15,000 patients has been published by Lencioni et al (2016) ⁽³⁾. They concluded that survival figures of HCC patients undergoing Lipiodol TACE was in line with those reported in previous randomized controlled trials and no new or unexpected safety concerns were identified and thus cTACE using Lipiodol remains the standard of care for HCC patients at intermediate stage. Technical recommendations have also been recently published by de Baère et al (2015) ⁽⁴⁾ and Miyayama & Matsui (2016) ⁽⁵⁾.  

cTACE has been recognized as the gold standard for the treatment of patients with intermediate-stage HCC by several international clinical consensus guidelines in Japan, Europe and the United States. These consensus guidelines unanimously recommend cTACE as the standard-of-care for patients with intermediate-stage HCC ^(6,7,8). These are level of evidence 1iiA recommendations with a grade of recommendation 1A made in European guidelines ⁽⁷⁾.

The guidelines ⁽⁷⁾ stipulate that such patients have a median survival of just 16 months, whereas cTACE extends the survival of these patients to a median of 20 months, representing four additional months. 

Consequently, treatment with cTACE is constantly increasing on all continents, with more than 400,000 patients being treated every year ⁽⁹⁾. 

References

¹ WHO, Globocan 2012 (IARC), Section of Cancer Surveillance (9/7/2014). 

² Kan Z. et al., Liver anatomy: microcirculation of the liver, Sem. Intervent. Radiology 2008; 25: 77-85.

³ Lencioni R, de Baère T, Soulen M et al. Lipiodol Transarterial Chemoembolization for Hepatocellular Carcinoma: A Systematic Review of Efficacy and Safety Data. Hepatology 2016; 64: 106-116. 

⁴ De Baère T, Arai Y, Lencioni R et al Treatment of liver tumors with Lipiodol TACE: technical   recommendations from experts opinion. Cardiovasc Intervent Radiol 2015; 39: 334–343. 

⁵ Miyayama S, Matsui O. Superselective conventional transarterial chemoembolization for hepatocellular carcinoma: rationale, technique and outcome. J Vasc Interv Radiol 2016; 27: 1269-1278.

⁶ Japan Society of Hepatology, Recommendation, Chapter 5 (CQ44, page 105); Hepatology Research 2010; 40 (Suppl.1): 96-112.

⁷ EASL-EORTC Clinical Practice Guidelines: Management Association of Study of Liver Disease & European Organization Cancer); Journal of Hepatology 2012, Vol. 56, j 908-943.

⁸ AASLD Practice Guidelines; American Association for Study of the Liver Diseases; HEPATOLOGY, Vol. 53, No. 3, 2011.

⁹ Guerbet data 1997-2017

Press release

About Lipiodol^® Ultra Fluid

Lipiodol^® Ultra Fluid (ethyl esters of iodized fatty acids of poppyseed oil) was initially developed for diagnostic radiology in indications including liver lesion diagnosis, lymphography and hysterosalpingography, and then used in interventional radiology for conventional trans-arterial chemo-embolization (cTACE) procedures of multinodular hepatocellular carcinoma, where Lipiodol^® Ultra Fluid is used as a procedure visualizer (contrast agent), a drug vehicle (drug carrier), and an embolic. The approved indications for Lipiodol^® Ultra Fluid may vary according to countries. Please refer to local SmPC for further information.

Lipiodol^® Ultra Fluid is not commercialized in Spain.

cTACE is an indication not authorized in Spain.