FDA Approval Insights: TheraSphere Y-90 Glass Microspheres in HCC

Riad Salem, MD, discusses the unique elements of the TheraSphere, the data that supported the regulatory approval, and the anticipated future for the radioembolization technology in hepatocellular carcinoma.

Welcome to OncLive On Air™. I’m your host today, Jessica Hergert.

OncLive On Air™ is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions. 

In today’s episode, sponsored by Boston Scientific, we had the pleasure of speaking with Riad Salem, MD, vice chair for Image Guided Therapy in the Department of Radiology and chief of Vascular and Interventional Radiology in the Department of Radiology, at Northwestern Medicine, and professor of Radiology (Vascular and Interventional Radiology), Medicine (Hematology and Oncology) and Surgery (Organ Transplantation) at the Feinberg School of Medicine, to discuss the excitement surrounding the FDA approval of TheraSphere™ Yttrium-90 (Y-90) Glass Microspheres for the treatment of patients with hepatocellular carcinoma (HCC).

The March 18, 2021 FDA approval is based on findings from the retrospective LEGACY trial, in which TheraSphere, a personalized radiotherapeutic cancer treatment, elicited an overall response rate of 72.2% at 4 weeks per blinded independent central review as neoadjuvant or stand-alone treatment in 162 evaluable patients with unresectable HCC.

Data also showed that the 6-month duration of response rate was 76.1% with TheraSphere per modified RECIST criteria, meeting both primary end points of the study.

TheraSphere is now the only radioembolization technology indicated for the treatment of patients with unresectable HCC in the United States, according to Boston Scientific Corporation, the developer of the product.

In our exclusive interview, Salem, a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, discussed the unique elements of the radioembolization technology, the data that supported the regulatory approval, and the anticipated future for TheraSphere in HCC.