Dr. Padia on Data Supporting FDA Approval of Y-90 Glass Microspheres in HCC

Siddharth Padia, MD, a specialist in vascular and interventional radiology at the University of California, Los Angeles Medical Center, discusses the data that led to the March 2021 FDA approval of TheraSphere™ Yttrium-90 (Y-90) Glass Microspheres for use in patients with hepatocellular carcinoma (HCC).

This is the first device that is approved for HCC in the United States based on data from the following 3 studies: the phase 2 DOSISPHERES-01 trial (NCT02582034), the LEGACY trial, and the TARGET trial (NCT03295006). Results from the trials demonstrated that the approval of this approach was warranted, according to Padia. The TARGET study, however, specifically identified uniform results across multiple institutions, which helped to alleviate concerns that the device could only be optimally used at certain centers, Padia says. Additionally, all 3 studies demonstrated that with the right experience, results could be translatable from one operator to the next, Padia concludes.