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National Medical Products Administration (NMPA) approves Lipiodol® Ultra-Fluid for trans-arterial chemoembolization for hepatocellular carcinoma (HCC) at intermediate-stage in adult patients in China

National Medical Products Administration (NMPA) approves Lipiodol® Ultra-Fluid for trans-arterial chemoembolization for hepatocellular carcinoma (HCC) at intermediate-stage in adult patients in China

06/09/2020
Villepinte (France), June 9, 2020 - 6:00 pm CET - Guerbet (GBT), a global leader in medical imaging announced the approval of an additional indication for Lipiodol® Ultra-Fluid by the China NMPA (National Medical Products Administration) for use in Trans-Arterial Chemo-Embolization (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 cases1.
"Guerbet is honored 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 hepatocellular carcinoma 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 trans-arterial 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 loco-regional 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 & radiation oncology, since the evidence supporting loco-regional image-guided cancer therapies has significantly grown in recent years as have the range of treatments and applications available.
 
Lipiodol® Ultra-Fluid is used in conventional trans-arterial chemo-embolization procedures for the treatment of patients with inoperable liver tumours. cTACE has been published in over 100 clinical studies, of which five were international RCTs, on more than 10,000 patients with intermediate stage HCC.
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 32 months8, or even 37 months9. therefore up to 7 additional months.
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 year10.
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).
The recent approval of Lipiodol® Ultra-Fluid for cTACE in China highlights Guerbet 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 of 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 trans-arterial 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 loco-regional targeted chemotherapy, in which Lipiodol® Ultra-Fluid acts as a contrast agent, a drug vehicle and a dual arterio-portal transient embolic(2). 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 local SmPC for further information.
About Guerbet
Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients. A pioneer since more than 90 years in the field of contrast media with over 2,800 people globally, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B - mid caps) and generated €817 million in revenue in 2019. For more information about Guerbet, please visit www.guerbet.com.
 
References
1 WHO , cancer today Liver Source: Globocan 2018
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
4 Kokudo 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
5 Liver 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 Cheung Liver Cancer. 2018 Mar; 7(1): 40-54.
7 Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update Masao Omata Hepatol Int. 2017 Jul; 11(4): 317-370
8 Kudo M et al. Lancet Gastroenterol Hepatol 2018; 3:37-46
9 Ikeda M et al. J Gastroenterol 2018; 53:281-290
10 Guerbet data 1997 to 2019.
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