FDA Approves Radiation Therapy for Outpatient Setting in Liver Cancer Subtype

The Food and Drug Administration (FDA) recently approved TheraSphere™ Yttrium-90 (Y-90) Glass Microspheres for patients with hepatocellular carcinoma, according to the therapy’s manufacturer, Boston Scientific. This is now the only radioembolization treatment approved in the United States for these specific patients, according to the manufacturer.

Radioembolization is a minimally invasive procedure where physicians are able to deliver radiation directly into a patient’s tumor.

Hepatocellular carcinoma is the most common type of primary liver cancer and, according to estimates from the American Cancer Society, approximately 32,000 people in the U.S. are expected to be diagnosed with the disease in 2021.

Prior to this approval, the therapy was being administer under the FDA’s humanitarian device exemption, which limits the number of people that can be treated with a therapy each year.

TheraSphere, according to the manufacturer, is a type of selective internal radiation therapy which consists of millions of microscopic glass beads that contain radioactive material that is directly delivered to liver tumors via a catheter. The aim of the therapy is to limit radiation exposure to surrounding healthy tissue around the cancerous tumors.

The FDA based its decision on study results from the LEGACY trial, which was designed to assess the safety and efficacy of TheraSphere™ Y-90 Glass Microspheres in 162 patients with early and advanced hepatocellular carcinoma.

Measuring objective response rate (the proportion of patients who had a complete or partial response to treatment) and duration of response were the main goals of the study. Treatment with TheraSphere was associated with an objective response rate of 72.2% at four weeks and a duration of response of 76.1% at six months.

The study results also showed that each patient reached a complete or partial response up to two treatments with the therapy. Moreover, the three-year overall survival rate was 93% in patients who had a transplant or resection after treatment.

“I am honored to have spearheaded the LEGACY trial in which we found that patients with early and advanced (hepatocellular carcinoma) exhibited very high response rates, as well as clinically meaningful durations of response and survival – establishing TheraSphere as a standard treatment for this patient population,” said lead study author Dr. Riad Salem, an interventional radiologist at Northwestern Memorial Hospital in Chicago, in a news release.

Patients who are receiving the treatment do not need to be hospitalized, according to Boston Scientific, and can typically receive the therapy in approximately an hour during an outpatient procedure.

“The FDA approval and the recent (National Institute for Health and Care Excellence) recommendation will expand access to TheraSphere, which has demonstrated improvement in both survivability and quality of life through 20 years of clinical trials and real-world outcomes in the more than 70,000 patients globally,” said Peter Pattison, president of interventional oncology, a peripheral interventions at Boston Scientific, in the news release.

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