Dr. Salem on the FDA Approval of Y-90 Glass Microspheres for HCC

Riad Salem, MD, vice chair for Image Guided Therapy, Department of Radiology, chief of Vascular and Interventional Radiology in the Department of Radiology, and professor of Radiology (Vascular and Interventional Radiology), Medicine (Hematology and Oncology) and Surgery (Organ Transplantation) at the Feinberg School of Medicine, discusses the FDA approval of TheraSphere™ Yttrium-90 (Y-90) Glass Microsphere in March 2021 for the treatment of patients with hepatocellular carcinoma (HCC).

The approval stems from a collaboration between investigators, regulators, and the industry to generate a multicenter dataset that had demonstrated compelling outcomes, Salem says; these outcomes were strong enough to lead to approval of this approach. The regulatory decision possesses the potential to make Y-90 more widely available as a treatment option in more cancer centers, Salem notes.

Patients will benefit from having increased treatment options, Salem adds. Additionally, the approval of Y-90 is something that can be implemented in not only high-volume, highly specialized cancer centers, but also in other more low-volume centers that have the expertise to utilize Y-90 in a clinical setting, as well, Salem concludes.