Bonn, Germany (16 March 2016) – Sirtex (ASX:SRX) announced that the Netherlands Healthcare Institute, Zorginstituut Nederland (ZIN), has agreed to reimburse Selective Internal Radiation Therapy (SIRT) for patients with colorectal liver metastases who have failed on or are intolerant to prior chemotherapy. The ZIN based its decision on clinical evidence of the efficacy and safety of SIR-Spheres® Y-90 resin microspheres for treating this patient group.
It was also announced that The Netherlands Comprehensive Cancer Organisation, Integraal Kankercentrum Nederland (IKNL), will manage a new patient registry to collect and analyse treatment data on the first 500 patients with colorectal liver metastases who receive SIRT under the new reimbursement programme.
SIR-Spheres Y-90 resin microspheres are a medical device used in an interventional radiology procedure known as SIRT or radioembolisation, which targets high doses of radiation directly to liver tumours. The treatment will be made available to patients in The Netherlands through 10 specialist centres.
Colorectal cancer is the most frequently diagnosed cancer in The Netherlands, with 13,900 new patients annually; it is also the country’s second most common cause of cancer mortality, accounting for approximately 5,200 deaths each year.1 When colorectal cancer spreads (metastasizes) elsewhere in the body, it most often spreads to the liver. These liver metastases will eventually cause the death of the majority of patients.
“This announcement is very good news for the many patients in The Netherlands with liver metastases from colorectal cancer who have failed chemotherapy and biological treatments,” said Professor Marnix Lam, Nuclear Medicine Physician at University Medical Center Utrecht.
Ms. Gerda Schapers, a survivor of advanced metastatic colorectal cancer and a board member of The Dutch Intestinal Cancer Foundation stated, “I am delighted that patients from all over The Netherlands can now benefit from this innovative therapy, with which I was treated more than three years ago.”
“We are pleased that SIR-Spheres will now be available to more patients at leading specialist centres across The Netherlands. This decision affirms the strong evidence of efficacy and safety for SIR-Spheres in this patient group” said Nigel Lange, Chief Executive Officer of Sirtex Medical Europe, whose parent company, Sirtex Medical Limited, developed and continues to study new uses of SIR-Spheres Y-90 resin microspheres in the treatment of liver tumours.
What is Selective Internal Radiation Therapy (SIRT)?
Selective Internal Radiation Therapy (SIRT) is a non-surgical procedure, in which an interventional radiologist uses a catheter directed through an incision in the patient’s femoral artery to deliver a treatment comprising millions of radioactive microspheres (more than 30 million resin microspheres coated in radioactive yttrium-90 in the case of SIR-Spheres microspheres) directly into branches of the hepatic (liver) artery. The microspheres are carried by the blood flow through the arteries into the small vessels that nourish tumours in the liver, where they ultimately become trapped due to their size and deliver high doses of beta-radiation directly to the tumours. As internal radiation is delivered directly to tumours, patients can receive radiation doses many times greater than possible with external beam radiation.
About SIR-Spheres microspheres:
SIR-Spheres Y-90 resin microspheres are approved for use in Australia, the United States of America (FDA PMA approval), the European Union (CE Mark), Argentina (ANMAT), Switzerland, Turkey, and several other countries in Asia such as India, and Singapore. Additionally, SIR-Spheres Y-90 resin microspheres are supplied in countries such as Hong Kong, Israel, Malaysia, New Zealand, Taiwan and Thailand. SIR-Spheres Y-90 resin microspheres are indicated in the United States for the treatment of non-resectable metastatic liver tumours from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine. SIR-Spheres Y-90 resin microspheres are indicated for the treatment of inoperable liver tumours in Australia, the European Union, Argentina, Brazil, and several countries in Asia, such as India and Singapore.
Sirtex Medical Limited (ASX: SRX) is an Australian-based global healthcare business working to improve treatment outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres Y-90 resin microspheres. Approximately 55,000 doses have been supplied to treat patients with liver cancer at more than 900 medical centres in over 40 countries. For more information, please visit www.sirtex.com.
SIR-Spheres® is a Registered Trademark of Sirtex SIR-Spheres Pty Ltd.
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Effective May 7, 2021, SIR-Spheres will have the following indication for use:
SIR-Spheres Y-90 resin microspheres are indicated for the treatment of unresectable hepatocellular carcinoma (HCC) and unresectable metastatic liver tumors from primary colorectal cancer in patients refractory to or intolerant of chemotherapy.
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