Sirtex SIR-Spheres Approved for HCC Treatment by Brazil’s National Agency of Supplementary Health

September 15, 2022—Sirtex Medical announced that the Brazilian National Agency of Supplementary Health (ANS) approved the company’s 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, a minimally invasive treatment that delivers high doses of radiation directly to tumors while sparing surrounding healthy liver tissue.

Sirtex received product approval for SIR-Spheres from ANVISA, the Brazilian Health Regulatory Agency, in 2014. In Brazil, liver cancer is the 11th highest cancer incidence, representing 2.1% of new cases and 4.7% of total cancer-related deaths.

Joaquim Maurício da Motta Leal Filho, MD, President of the Brazilian Society of Interventional Radiology and Endovascular Surgery, commented in the company’s press release, “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. 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 Argentina, Australia, Switzerland, Turkey, and several countries in Asia for the treatment of unresectable liver tumors. In February 2022, Sirtex annnounced with its shareholder, Grand Pharmaceutical Group Limited, that SIR-Spheres were approved by China’s National Medical Products Administration for the treatment of patients with colorectal cancer liver metastases.

In the United States, SIR-Spheres Y-90 resin microspheres received premarket approval from the FDA and are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intrahepatic artery chemotherapy of floxuridine, advised Sirtex.