The FDA granted MDS Nordion, which makes TheraSphere, a Humanitarian Device Exemption. This exemption, which permits the FDA to approve devices based on proof of patient safety alone, encourages further research and development for diseases that affect few patients. Those less responsive to TheraSphere as a treatment option are patients who have larger liver tumors, for example. TheraSphere is a non-surgical outpatient procedure. Patients can return home the same day and treatment poses no safety threat to caregivers or family members.
Side effects can include vomiting, mild fever, abdominal pain and gastric ulcers.
Toxicities are evident in about 20 percent of patients treated. Although patients initially were treated with a single dose, the procedure is being evaluated as a two-part process in which the right lobe of the liver is treated and the left lobe is treated two to four weeks later. Surgery remains the preferred treatment, but fewer than 15 percent of patients qualify for that option due to the advanced progression of the disease. And, though liver cancer is more prevalent in other countries such as Africa and Asia, it is on the rise in the United States due to the increasing number of persons who have the Hepatitis B or C virus. Any question regarding a medical diagnosis, treatment, referral, drug availability or pricing should be directed to either a licensed physician or to the product's manufacturer.