Sirtex SIR-Spheres Receive Expanded CE Mark Approval to Treat Liver Cancer

September 10, 2025—Sirtex Medical announced that it has received an expanded CE Mark approval for SIR-Spheres yttrium-90 (Y90) resin microspheres for the radioembolization treatment of patients with liver cancer. With this expansion, eligibility now covers both primary and secondary liver metastases for this targeted oncology therapy.

Sirtex noted that the CE Mark expansion comes after an extensive review of clinical data demonstrating the safety and effectiveness of SIR-Spheres across diverse liver metastases.

According to the company, selective internal radiation therapy delivers Y90 directly to tumors via the hepatic artery, allowing for high-dose, targeted radiation while aiming to minimize impact to surrounding healthy tissue.

“Y90 radioembolization has long demonstrated clinical value in managing complex liver tumors,” commented Professor Jens Ricke, MD, in the company’s press release.

Prof. Ricke, Director of the Clinic and Polyclinic of Radiology at the University Hospital Ludwig-Maximilians in Munich, Germany, continued, “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.”

Sirtex advised that in Europe, SIR-Spheres Y90 resin microspheres are indicated for the treatment of unresectable hepatocellular carcinoma (HCC), unresectable metastatic liver tumors from primary colorectal cancer in patients refractory to or intolerant of chemotherapy, unresectable intrahepatic cholangiocarcinoma, hepatic metastases by neuroendocrine tumors, and other liver metastases.

In July 2025, the company announced FDA approval of SIR-Spheres Y90 resin microspheres for the treatment of unresectable HCC in the United States.