Dr. Kim on the FDA Approval of TheraSphere Y-90 Glass Microspheres in HCC

Edward Kim, MD, director, Interventional Oncology, assistant professor of radiology and surgery, Division of Vascular and Interventional Radiology, Mount Sinai Medical Center, discusses the FDA approval of TheraSphere™ Yttrium-90 (Y-90) Glass Microspheres in hepatocellular carcinoma (HCC).

On March 18, 2021, the FDA approved TheraSphere, a personalized radiotherapeutic cancer treatment, for use in patients with HCC based on data from the retrospective LEGACY trial, says Kim. The results showed that the therapy led to an objective response rate of 72.2% as neoadjuvant or stand-alone treatment. Currently, TheraSphere, which was under clinical development for decades, is the only approved interventional radiology treatment for patients with HCC, Kim explains.

Patients in the LEGACY trial had tumors between 1 and 8 cm, Kim says. Notably, the rate of best response to TheraSphere was 88%. Moreover, 76.1% of patients derived a duration of response rate at 6 months with TheraSphere, Kim says. The long duration of response serves as a surrogate for pathologic necrosis, concludes Kim.