Sirtex Medical secures positive approval of SIR-Spheres Y-90 resin microspheres for HCC treatment in Brazil

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DOORwaYSirtex Medical announced that the Brazilian National Agency of Supplementary Health (ANS) approved SIR-Spheres Y-90 resin microspheres for the treatment of intermediate- and advanced-stage hepatocellular carcinoma (HCC) in Brazil.

In an update to its List of Health Procedures and Events, ANS recommends SIR-Spheres for use in selective internal radiation therapy (SIRT), a minimally invasive treatment that delivers high doses of radiation directly to tumours while sparing surrounding healthy liver tissue. Sirtex received product approval from the Brazilian Health Regulatory Agency (ANVISA) for SIR-Spheres in 2014.

“This milestone represents the close collaboration we have fostered with Brazilian colleagues, interventional radiologists and respected regulatory entities like ANS over the last six years,” said Kevin R Smith, chief executive officer of Sirtex. “We celebrate the recognition of SIR-Spheres to advance care for HCC patients, and we also reaffirm our commitment to global growth and partnership for more effective cancer treatment worldwide.”

The proposals for incorporation into the ANS List of Health Procedures and Events underwent broad social participation and careful technical analysis by the ANS, using the methodology of health technology assessment, similar to EnglandCanadaAustralia and Germany.

“The ANS recommendation of SIR-Spheres solidifies it as a valuable treatment option, especially since 76% of HCC patients in Brazil are diagnosed at an advanced stage when treatments of curative intent are no longer an option,” said Joaquim Maurício da Motta Leal Filho (Universidade de São Paulo, São Paulo, Brazil), president of the Brazilian Society of Interventional Radiology and Endovascular Surgery (SOBRICE). “As we continuously strive to improve outcomes for patients, we are proud of this achievement and feel gratitude to the many people who contributed to this decision.”

In addition to Brazil, SIR-Spheres are approved for use in ArgentinaAustraliaSwitzerlandTurkey, and several countries in Asia for the treatment of unresectable liver tumours. In the USA, SIR-Spheres Y-90 resin microspheres have a Pre-Market Approval (PMA) from the US Food and Drug Administration (FDA) and are indicated for the treatment of unresectable metastatic liver tumours from primary colorectal cancer with adjuvant intrahepatic artery chemotherapy (IHAC) of FUDR (floxuridine).


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