<strong>Therapeutic Goods Administration (TGA) approves both an additional indication for Guerbet’s Lipiodol<sup>®</sup> Ultra-Fluid & Vectorio<sup>®</sup> in Australia</strong>

Therapeutic Goods Administration (TGA) approves both an additional indication for Guerbet’s Lipiodol® Ultra-Fluid & Vectorio® in Australia

Lipiodol® Ultra-Fluid is now approved as an imaging agent for visualization and localization during Trans-Arterial Chemo-Embolization of hepatocellular carcinoma (HCC) and Vectorio® as mixing and injection system for conventional Trans-Arterial Chemo-Embolization (cTACE)

Villepinte (France), June 16, 2020 - 6:00 pm CET - Guerbet (GBT), a global leader in medical imaging announced the approvals of an additional indication for Lipiodol® Ultra-Fluid by the TGA (Therapeutic Goods Administration) in Australia for use as imaging agent for visualization and localization during trans-arterial chemo-embolization of hepatocellular carcinoma (HCC) at intermediate stage in adults and for Vectorio®, mixing and injection system for cTACE.

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

The approval of the well-established conventional trans-arterial chemo-embolization treatment is a great step forward for liver cancer patients in Australia. Combined with the Vectorio® innovative cTACE mixing and injection system, preparation of the Lipiodol®-chemotherapy mixture will be much easier for Interventional Radiologists” commented Doctor Gerard Goh, The Alfred Hospital and Monash University & President of the Interventional Radiology Society of Australasia (IRSA).

Lipiodol® Ultra-Fluid is used 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.

Vectorio® is a set of Lipiodol® Ultra-Fluid resistant medical devices3 including patented syringes, stopcock and sampling devices. This set is dedicated for mixing and injecting Lipiodol® Ultra-Fluid and anticancer drug during cTACE procedures.

This medical device:

  • Is resistant 24 hours to Lipiodol® Ultra Fluid3
  • Contains Patented 3-way stopcock with 4 connections offering possibility of “On-table remix & optimized injection control” (interventional radiologists have the possibility of refill without disconnection from the micro-catheter)
  • Contains all devices in one set
  • Is user-friendly: ergonomic and quick device set-up

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 available range of treatments and applications.

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, all China territories, India, Mongolia, New Zealand, Philippines, South Korea, Sri Lanka, Thailand, Vietnam.

Lipiodol® Ultra-Fluid is approved for Imaging of patients with known Hepato-Cellular 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.

Vectorio® is registered as cTACE mixing & injection system in EMEA (Austria, Belgium, Czech Republic, Denmark, France, Hungary, Ireland, Luxembourg, Portugal, Switzerland, The Netherlands, Turkey), Americas (Argentina, Brazil, Colombia, Ecuador, Mexico, Peru) and Asia-Pacific (Australia, Hong Kong, India, New Zealand, South Korea, Taiwan, Thailand, Vietnam).

Vectorio® is also registered as kit for imaging of hepatocellular carcinoma in Canada and in Germany.

These two approvals of Lipiodol® Ultra-Fluid for cTACE & Vectorio® in Australia highlight Guerbet’s strategy to develop its interventional imaging business unit and invest in clinical and R&D programs to deliver enhanced and innovative interventional oncology therapies.

Lipiodol® Ultra-Fluid is used in conventional trans-arterial chemo-embolization procedures for the treatment of patients with inoperable liver tumors. cTACE has been published in over 100 clinical studies, of which five were international randomized clinical trials, 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 HCC4,5,6,7,8.

EASL4 guidelines stipulate that these patients present a median survival of 2.5 years after TACE whereas cTACE extends the survival of these patients up to 32 months9 to 37 months10.Therefore up to 7 additional months.

 

About cTACE

Conventional trans-arterial 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 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 Trans-Arterial Chemo-Embolization 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 Vectorio®

Vectorio® is a sterile medical device of class Is (CE 0459) intended to be used by healthcare professionals only. Its functionality has been verified up to 24h in contact with Lipiodol® Ultra Fluid3. Intended use: Lipiodol® Resistant Mixing & Injection System for conventional Trans-Arterial Chemo-Embolization (cTACE). For complete information about precautions and optimal usage conditions, we recommend consulting the instruction for use supplied with the device or by your local Guerbet representative(s). For use only in countries with applicable health authority registrations. Vectorio® is manufactured by Medex, a Guerbet group company.

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.

3Test report (E17-41) – Verification report of the device’s functionality after 24h

exposure to Lipiodol®

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

5 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

6 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,

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

8 Asia–Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update Masao Omata Hepatol Int. 2017 Jul; 11(4): 317–370

9 Kudo M et al. Lancet Gastroenterol Hepatol 2018; 3:37-46

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

 

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