ACRES Commercial

FDA Approves SIR-Spheres Y-90 Resin Microspheres for Unresectable Hepatocellular Carcinoma

- The FDA has approved SIR-Spheres Y-90 resin microspheres for treating patients with unresectable hepatocellular carcinoma who have no macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and good performance status. - The approval was supported by the DOORwaY90 phase 3 trial, which demonstrated a 98.5% objective response rate and 100% local tumor control rate in 100 patients across 18 U.S. centers. - The treatment represents a paradigm shift for transplant-eligible patients, offering prolonged local control with no tumor progression observed at one year of follow-up. - The study utilized advanced partition dosimetry treatment planning with centralized oversight, marking the first prospective U.S. trial to implement this standardized approach for Y-90 therapy.