FDA Approves Radioembolization Therapy for Unresectable Hepatocellular Carcinoma

Interventional radiologists have a new modality for treating hepatocellular carcinoma (HCC) with the Food and Drug Administration (FDA) issuing an expanded approval for SIR-Spheres Y-90 resin microspheres in the management of unresectable HCC.

Previously approved for the treatment of metastatic colorectal cancer, the SIR-Spheres radioembolization therapy was recently evaluated for the treatment of HCC in the prospective multicenter DOORwaY⁹⁰ study.

Employing personalized dosimetry for the direct delivery of optimal radiation dosing to HCC tumors, researchers found that SIR-Spheres (Sirtex Medical) achieved a 98.5 percent overall response rate, and that the median duration of response exceeded 300 days.

“This study moves the field of radioembolization forward with reproducible dosimetry outcomes and a strong safety profile linked to very positive clinical results. This will give multidisciplinary care teams the confidence to recommend SIR-Spheres for HCC treatment,” noted Armeen Mahvash, M.D., a professor in the Department of Interventional Radiology at the University of Texas MD Anderson Cancer Center in Houston, and a co-principal investigator of the DOORwaY⁹⁰ study.