Sirtex Medical today announced that it has received an expanded CE mark approval for SIR-Spheres yttrium 90 (Y90) resin microspheres for the treatment of patients with liver cancer. With this expansion, eligibility now covers both primary and secondary liver metastases.
“This milestone is about more than regulatory approval—it’s about giving hope and options back to patients facing some of the toughest cancer diagnoses,” said Matt Schmidt, chief executive officer of Sirtex Medical. “By expanding access to SIR-Spheres, we’re ensuring that more people can benefit from a well-tolerated therapy when they need it most.”
Radioembolization—also known as selective internal radiation therapy (SIRT)—delivers Y90 directly to tumours via the hepatic artery, allowing for high-dose, targeted radiation aiming to minimise impact to surrounding healthy tissue.
“Y-90 radioembolization has long demonstrated clinical value in managing complex liver tumours,” said Jens Ricke, director of the clinic and polyclinic of radiology at the University Hospital Ludwig-Maximilians in Munich, Germany. “With this expanded CE mark, more patients will have access to a therapy that can extend life, improve quality of life, and offer hope when other treatments may no longer be effective.”
The CE mark expansion follows an extensive review of clinical data demonstrating the safety and effectiveness of SIR-Spheres across diverse liver metastases. Together with the US Food and Drug Administration (FDA)’s recent approval of SIR-Spheres Y90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the United States, this milestone underscores the growing global recognition of SIR-Spheres as a versatile, differentiated therapy and reinforces the Sirtex commitment to advancing liver-directed interventional oncology, says the company in a recent press release.
