jueves, 6 de junio de 2019

New indication approved for Guerbet's Lipiodol® Ultra Fluid


- Guerbet (GBT) announced that it has been granted approval for a new indication for Lipiodol® Ultra Fluid in Switzerland and in India for chemoembolization (cTACE) of tumors in adults with known intermediate-stage hepatocellular carcinoma (HCC).
HCC is the most common primary liver cancer and is the 4th leading cause of annual cancer death worldwide [1].
"Guerbet is proud to have received approval for this new indication for Lipiodol® Ultra Fluid. This is evidence of our commitment to making c-TACE available to as many HCC patients as possible." said Thomas Bonnefont, Guerbet's VP for Interventional Imaging. "Development of these image-guided procedures is a top priority for Guerbet's Interventional Imaging Franchise as we work to enhance liver cancer patients' prognosis and quality of life worldwide."

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 indication is now approved in EMEA (Austria, Belgium, Czech Republic, France,  Hungary, Iran, Ireland, Luxemburg, the Netherlands, Portugal, Switzerland, Turkey), APAC (Cambodia, Hong Kong, India, Mongolia, New Zealand, Philippines, South Korea, Taiwan, Thailand, Vietnam), and Latin America (Argentina, Brazil, Mexico, Peru).
HCC imaging indication is now approved in Canada, Germany and in the USA.
The approval in Switzerland and in India 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 [4], [5] 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) [6] and Miyayama & Matsui (2016) [7].  
cTACE has been recognized as the gold standard for the treatment of patients with intermediate-stage HCC by several international clinical consensus. These consensus guidelines unanimously recommend cTACE as the standard-of-care for patients with intermediate-stage HCC [8], [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 year [11].

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