TheraSphere® Recommended by the National Institute for Health and Care Excellence (NICE) for the Treatment of Primary and Secondary Liver Cancer

TheraSphere® Recommended by the National Institute for Health and Care Excellence (NICE) for the Treatment of Primary and Secondary Liver Cancer 

LONDON, July 30, 2013 /PRNewswire/ --

BTG plc (LSE: BTG), the specialist healthcare company, today announces that the National Institute for Health and Care Excellence (NICE) has issued guidance recommending the use of Selective Internal Radiation Therapy (SIRT)(1), which includes TheraSphere®, for patients with liver cancer across the NHS. The guidance supports the use of this innovative treatment for patients with primary hepatocellular carcinoma as well as for those with intrahepatic cholangiocarcinoma(2) and follows the previous recommendation for its use in patients with colorectal cancer liver metastases(3).

The NHS in England is currently preparing guidelines on how SIRT should be used as a treatment option for patients with liver cancer, including those with colorectal cancer liver metastases and cholangiocarcinoma, after recently issuing an interim policy on how this therapy should be funded(4). It is anticipated that this latest NICE guidance will result in a similar evaluation for patients with primary liver cancer. "NICE's guidance further highlights the growing acceptance and understanding of radioembolization in the treatment of liver cancer," said Peter Pattison, General Manager TheraSphere®. "With over 4,000 new liver cancer cases diagnosed annually in the UK(5), this new guidance will potentially provide patients with access to a broader range of treatment options."

Pattison added: "With many countries looking to the UK for direction on their own reimbursement decisions and processes, this guidance should lead to greater awareness amongst physicians and patients and may also prompt similar guidance in other geographies. In addition to increasing liver cancer treatment options for physicians and patients in the UK, this guidance will assist BTG as we continue to explore other reimbursement opportunities in various regions across the world."

About TheraSphere®

TheraSphere is a form of radioembolization therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-90 (Y-90). The product is injected by physicians into the artery of the patient's liver through a catheter, which allows for a high dose of radiation to be delivered directly to the tumour via blood flow thereby limiting the damage to surrounding healthy tissue and side effects to the patients.

TheraSphere is used in the European Union and in Canada for the treatment of hepatic neoplasia in patients who have appropriately positioned arterial catheters. Since its introduction in Europe, more than 1,000 patients have been treated with TheraSphere.

Common side effects include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu. Some patients experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to the TheraSphere package insert/instructions for use at http://www.nordion.com/therasphere.
National Institute of Care Excellence. IPG460 Selective internal radiation therapy for primary hepatocellular carcinoma: guidance. London. 24 July 2013.

National Institute of Care Excellence. IPG459. Selective internal radiation therapy for primary cholangiocarcinoma. London. 24 July 2013.

National Institute of Care Excellence. IPG401. Selective internal radiation therapy for non-resectable colorectal metastases of the liver: guidance. London. July 2012 (updates May 2013).
NHS England. Interim Clinical Commissioning Policy Statement: Selective Internal Radiotherapy (SIRT). June 2013.
http://www.cancerresearchuk.org/cancer-info/cancerstats/types/liver/

About BTG

BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and varicose veins. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG please visit our website at http://www.btgplc.com.

http://www.prnewswire.co.uk/news-releases/therasphere-recommended-by-the-national-institute-for-health-and-care-excellence-nice-for-the-treatment-of-primary-and-secondary-liver-cancer-217517801.html

TheraSphere® Prolongs Liver Cancer Survival Rates

What Is TheraSphere ?

URMC Introduces TheraSphere Technology

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New European Study Shows TheraSphere® Prolongs Liver Cancer Survival Rates

MDS Nordion, a leading provider of products and services to the global health science market, today announced that the first large European study using Yttrium-90 (Y-90) glass microspheres has been published on the use of TheraSphere®, an innovative radioembolisation therapy for the localised treatment of patients with advanced hepatocellular carcinoma (HCC) or primary liver cancer.

The publication, which currently can
be viewed online/(*see abstract below) and is expected to appear in the November 2010 edition of Hepatology, concludes that radioembolisation with TheraSphere® is both safe and effective, and states that the overall survival rate is similar to that found in another recently published large study analysing Y-90 glass microspheres for the treatment of HCC.

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Conducted at MDS Nordion’s European Centre of Excellence in Essen, Germany, the study involved 108 patients, none of whom were eligible for conventional locoregional therapies. Patients achieved a median overall survival of 16.4 months with minimal damage to the surrounding healthy tissue, even in patients with advanced liver cirrhosis or portal vein thrombosis. No lung or visceral toxicity was observed.

The most frequently observed adverse event was a transient fatigue-syndrome.Philip Hilgard, MD, hepatologist and lead author of the paper says, “The outcomes of this study were not unexpected, but it was extremely important for us to be able to substantiate and verify the treatment here in Europe. We feel confident that the publication of our study will help towards giving more patients access to this advanced therapy.”

Full Article.

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About TheraSphere

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TheraSphere is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-90. The product is injected by physicians into the main artery of the patient’s liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood vessels.

TheraSphere treatment can generally be administered on an outpatient basis and does not usually require an overnight hospital stay. MDS Nordion is approved (CE Mark) in Europe to distribute TheraSphere for treatment of hepatic neoplasia. MDS Nordion established a European

TheraSphere Centre of Excellence in Essen, Germany to train and educate oncology professionals on the use of this innovative cancer treatment.In addition, there are multiple treatment centres across Europe, including the BCLC Group Hospital Clinic in Barcelona, Spain; Centre Eugene Marquis in Rennes, France; and Istituto Tumori in Milan, Italy.

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TheraSphere treatment has some common side effects, including mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the common flu. Some patients will experience some loss of appetite and temporary changes in several blood tests. For details on the rarer side effects, please refer to the Instructions for Use on our website at http://www.mdsnordion.com/

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TheraSphere

The Data

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Radioembolization with Yttrium-90 glass microspheres in hepatocellular carcinoma: European experience on safety and long term survival

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Philip Hilgard1,2,*,‡, Monia Hamami3, Amr El Fouly1, André Scherag4,
Stefan Müller3, Judith Ertle1, Till Heusner6, Andreas Paul5, Andreas Bockisch3,
Guido Gerken1, Gerald Antoch6DOI: 10.1002/hep.23944

http://onlinelibrary.wiley.com/doi/10.1002/hep.23944/abstract

(HEPATOLOGY 2010.)

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Abstract
Radioembolization has been demonstrated to allow locoregional therapy of patients with hepatocellular carcinoma not eligible for transarterial chemoembolization or other local therapies.

The aim of this study was to validate evidence of the safety and efficacy of this treatment in a European sample of patients with advanced HCC.

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Therefore, 108 consecutive patients with advanced HCC and liver cirrhosis were included. Y-90 microspheres were administered in a lobar fashion over the right or left branch of the hepatic artery.

The response to treatment was evaluated by CT imaging applying RECIST and WHO criteria with recent EASL/NCI amendments.

Time to progression and overall survival were estimated by the Kaplan-Meier method. 159 treatment sessions were performed ranging between 1 to 3 treatments per patient.

The mean radiation dose per treatment was 120 (±18) Gy.

According to EASL criteria, complete responses were determined in 3% of patients, partial responses in 37%, stable disease 53% and primary progression in 6% of patients. Time to progression was 10.0 months whereas the median overall survival was 16.4 months

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No lung or visceral toxicity was observed. The most frequently observed adverse events was a transient fatigue-syndrome.

Conclusions:

Radioembolization with Yttrium-90 glass microspheres for patients with advanced HCC is a safe and effective treatment which can be utilized even in patients with compromised liver function. Since TTP and survival appear to be comparable to systemic therapy in selected patients with advanced HCC, randomized controlled trials in combination with systemic therapy are warranted.

(HEPATOLOGY 2010.)