Villepinte (France), April 8, 2021 (6:00 p.m. CET) - Guerbet (FR0000032526 GBT), a global leader in medical imaging, has announced the approval of an additional indication for Lipiodol® Ultra-Fluid by the South African SAHPRA (national medical products administration) for use in conventional transarterial chemo-embolization (cTACE) for intermediate-stage hepatocellular carcinoma (HCC) in adult patients in South Africa.

HCC is the most common primary liver cancer and the third biggest cause of death due to cancer worldwide1.

'Guerbet is honored to receive the SAHPRA approval for this indication for Lipiodol® Ultra-Fluid in South Africa. Moreover, this new indication is fully aligned with our Guerbet Purpose revealed last week: 'Build lasting relationships so that we enable people to live better',' commented Philippe Havard, Head of Marketing Lipiodol® Oncology. '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 South Africa and worldwide.'

Lipiodol® Ultra-Fluid is used in interventional oncology for conventional transarterial chemo-embolization, 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®Ultra-Fluid acts as a contrast agent, a drug vehicle and a dual arterio-portal transient embolic2.

Interventional oncology is increasingly being recognized as the fourth pillar of cancer care, alongside surgical oncology, medical oncology and radiation oncology, since the evidence supporting locoregional image-guided cancer therapies has significantly grown in recent years, as has the range of treatments and applications available.

cTACE has been established as the standard of care for the treatment of patients with intermediate stage HCC by several international clinical consensus guidelines in China, Japan, South Korea, Europe and the US. These consensus guidelines recommend cTACE for patients with intermediate stage HCC3,4,5,6,7.

EASL3 guidelines stipulate that these patients present a median survival of 2.5 years after TACE whereas cTACE extends the survival of these patients to a maximum of 37 months8.

Consequently, cTACE as a standard of care for primary liver cancer therapy has increasingly been recognized and utilized on all continents, with more than 400,000 patients being treated every year.

For interventional oncology procedures, Lipiodol® Ultra-Fluid is approved for the cTACE indication in EMEA (Austria, Belgium, Czech Republic, Denmark, France, Hungary, Iran, Ireland, Luxembourg, Portugal, South Africa, 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).

This approval of Lipiodol® Ultra-Fluid for cTACE in South Africa bolsters Guerbet's strategy to develop its Interventional Imaging Business Unit and invest in R&D to deliver enhanced and innovative interventional oncology therapies.

Lipiodol® Ultra-Fluid is approved for imaging in patients with known hepatocellular carcinoma (HCC) in the US, in Canada and in Germany.

Lipiodol® Ultra-Fluid is approved for adjustment of epirubicin hydrochloride for transarterial injection in Japan.

About cTACE

Conventional transarterial chemo-embolization (cTACE) is a minimally invasive procedure which consists of mixing Lipiodol® Ultra-Fluid with an anticancer drug and injecting this treatment trans-arterially in the liver as a locoregional targeted chemotherapy, in which Lipiodol® Ultra-Fluid acts as a contrast agent, a drug vehicle and a dual arterio-portal transient embolic2. cTACE was first performed in Japan in 1982 and then used effectively throughout Asia, Europe, the Middle East and Africa, as well as North America.

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 lymphography and hysterosalpingography and then used in interventional oncology for conventional transarterial chemo-embolization (cTACE) procedures of multinodular hepatocellular carcinoma. The approved indications for Lipiodol® Ultra-Fluid may vary according to countries. Please refer to the local SmPC for further information.

About Guerbet

At Guerbet, we build lasting relationships so that we enable people to live better. This is our Purpose. We are a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging. A pioneer since 95 years in the field of contrast media, Guerbet is a team of over 2,600 people globally, continuously innovating with 10% of revenue dedicated to Research & Development across four centers in France, Israel and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B - mid caps) and generated €712 million in revenue in 2020. For more information, please visit www.guerbet.com.

References

1 WHO, Cancer Today, Liver Source: Globocan 2020.

2 Kan et al., Seminars in Interventional Radiology 2008; 25 (2): 7785.

3 EASL-EORTC Clinical Practice Guidelines for the Management of Hepatocellular Carcinoma. J. Hepatol. 2018

4Kokudo N , Clinical Practice Guidelines for Hepatocellular Carcinoma 2013:Japan Society of Hepatology Chapter 5 https://www.jsh.or.jp/English/guidelines_en/Guidelines_for_hepatocellular_carcinoma_2013

5Liver Cancer. 2018 Sep; 7(3): 235-260. Published online 2018 Jun 14. doi: 10.1159/000488035 PMCID: PMC6167671 PMID: 30319983 Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2017 Edition) Jian Zhou,

6 Hong Kong Consensus Statements for the Management of Unresectable Hepatocellular Carcinoma Tom Tan-To CheungLiverCancer. 2018 Mar; 7(1): 40-54.

7 Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update Masao OmataHepatol Int. 2017 Jul; 11(4): 317-370

8 Ikeda M et al. J Gastroenterol 2018; 53:281-290

Media relations
Guerbet Global
 Alize RP
Caroline Carmagnol / +33 (0)6 64 18 99 59 / guerbet@alizerp.com

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Guerbet SA published this content on 08 April 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 April 2021 18:47:06 UTC.