About TheraSphere^®

TheraSphere (radioembolisation) is a low toxicity, targeted liver cancer therapy that consists of millions of tiny glass beads containing radioactive yttrium-90. The glass radioactive beads (a mean diameter of 20-30 micrometers – about a third of a width of a human hair) are delivered directly to the liver tumours.

Your doctor injects TheraSphere into the hepatic artery of your liver through a small flexible tube known as a catheter. The tiny radioactive glass beads flow directly into the liver tumour via its own blood vessels and become permanently lodged in the small blood vessels of the tumour. The radiation destroys the tumour cells from within the tumour, with minimal impact to the surrounding healthy liver tissue. The radioactive microspheres will continue to emit radiation over the course of several weeks after TheraSphere treatment, and radiation levels will decrease to insignificant levels. TheraSphere treatment is commonly referred to as radioembolization or selective internal radiation therapy (SIRT).

TheraSphere treatment is typically a procedure that does not require extensive hospitalization. It is well tolerated by patients, with side effects that are normally milder than with many other liver cancer treatments. Because the procedure is directed to the liver tumour, there is minimal impact to non-targeted tissue. After treatment, most TheraSphere patients are eligible for further therapeutic options because the procedure does not block the vessels of the liver. TheraSphere treatment has some common side effects, including mild to moderate fatigue, and pain and nausea for about a week. Physicians describe these symptoms as similar to those of the common flu. Some patients may experience loss of appetite and temporary changes in liver blood tests. For details on rare or more severe side effects, please refer to the TheraSphere Package Insert & Instructions for Use.

In the US, TheraSphere is used to treat patients with unresectable hepatocellular carcinoma (HCC), the most common form of primary liver cancer, and can be used as a bridge to surgery or transplantation in these patients. It is also indicated for the treatment of HCC patients with portal vein thrombosis (PVT). Patients will typically receive 1.8 treatments over their lifetime. TheraSphere is approved by the U.S Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE). HDE approvals are based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established.

TheraSphere® is used in the treatment of hepatic neoplasia in the European Union and in Canada in patients who have appropriately positioned arterial catheters.