New indication approved for Guerbet’s Lipiodol® Ultra Fluid

New indication approved for Guerbet’s Lipiodol® Ultra Fluid

Villepinte (France) – November 19th, 2019 - 06:00pm - Guerbet (GBT) announced that it has been granted approval for a new indication for Lipiodol® Ultra Fluid in Denmark for chemoembolization (cTACE) of tumors in adults with known intermediate-stage hepatocellular carcinoma. Hepatocellular carcinoma is the most common primary liver cancer and is the 4th leading cause of annual cancer death worldwide1.

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. Lipiodol® Ultra Fluid acts as a contrast agent, a drug eluting vehicle, and a dual arterio-portal transient embolic2.

The approval in Denmark testifies to the Guerbet commitment to develop its Interventional Imaging franchise and invest in enhanced and innovative interventional oncology therapies.

cTACE indication is now approved in EMEA (Austria, Belgium, Czech Republic, Denmark, France, Hungary, Iran, Ireland, Luxemburg, the Netherlands, Portugal, Switzerland, Tunisia, Turkey), APAC (Cambodia, Hong Kong, India, Mongolia, New Zealand, Philippines, South Korea, Sri Lanka, Taiwan, Thailand, Vietnam), and Latin America (Argentina, Brazil, Mexico, Peru). Hepatocellular carcinoma imaging indication is now approved in Germany, Canada and in the USA.

Lipiodol® Ultra Fluid is used in cTACE procedures for the management of patients with hepatocellular carcinoma 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 hepatocellular carcinoma patients undergoing Lipiodol TACE was in line with those reported in previous randomized controlled trials4,5 and no new or unexpected safety concerns were identified and thus cTACE using Lipiodol remains the standard of care for patients with hepatocellular carcinoma at intermediate stage. Technical recommendations have also been recently published by de Baère et al (2015)6 and Miyayama & Matsui (2016)7.  

cTACE has been recognized as the gold standard for the treatment of patients with intermediate-stage hepatocellular carcinoma by several international clinical consensus. These consensus guidelines unanimously recommend cTACE as the standard-of-care for patients with intermediate-stage hepatocellular carcinoma8,9,10. cTACE has strong recommendation and high leave of evidence for patients at BCLC stage B in European guideline9. Median survival for untreated patients at an intermediate-stage is 16 months, while cTACE extended median survival of around 40 months in well-selected candidates with a state-of-the-art technique and a super-selective approach9, representing 24 additional months. Consequently, treatment with cTACE is constantly increasing on all continents, with more than 400,000 patients being treated every year11.

 

1 WHO, Globocan 2018: https://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf

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 Llovet JM, Real MI, Montana X, et al. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet 2002; 359: 1734-1739.

5 Lo CM, Ngan H, Tso WK, et al. Randomized controlled trial of transarterial lipiodol chemoembolisation for unresectable hepatocellular carcinoma. Hepatology 2002; 35: 1164-1171.

6 De Baère T, Arai Y, Lencioni R et al Treatment of liver tumors with Lipiodol TACE: technical recommendations from expert’s opinion. Cardiovasc Intervent Radiol 2015; 39: 334–343.

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

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

9 EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. European Association for the Study of the Liver. J Hepatol 2018, https://doi.org/10.1016/j.jhep.2018.03.019

10 Marrero JA, Kulik LM, Sirlin CB et al. Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology, 2018; 68: 723-750.

11 Guerbet data 1997-2017