Sirtex Medical has announced an expanded CE Mark approval for its SIR-Spheres® Y-90 resin microspheres, enhancing treatment options for patients with liver cancer across Europe and CE-marked territories. This approval now includes eligibility for both primary and secondary liver metastases, significantly broadening access to this targeted therapy.
CEO Matt Schmidt emphasized the importance of this milestone, stating, “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.” The expansion aims to ensure that more individuals can benefit from this well-tolerated treatment option at a critical time in their healthcare journey.
Radioembolization Offers Targeted Treatment
The technique known as radioembolization, or selective internal radiation therapy (SIRT), delivers yttrium-90 directly to liver tumors via the hepatic artery. This method allows for high-dose, targeted radiation while minimizing exposure to surrounding healthy tissue.
Prof. Dr. med. Jens Ricke, Director of the Clinic and Polyclinic of Radiology at the University Hospital Ludwig-Maximilians in Munich, Germany, noted the clinical value of Y-90 radioembolization, stating, “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 expanded CE Mark approval comes after a thorough review of clinical data demonstrating the safety and effectiveness of SIR-Spheres® across a range of liver metastases. This follows the recent approval from the FDA for SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the United States. Together, these developments underscore the growing global recognition of SIR-Spheres® as a versatile therapy.
Commitment to Advancing Oncology Solutions
Sirtex Medical is dedicated to advancing minimally invasive interventional oncology solutions. With offices in the U.S., Australia, Europe, and Asia, the company focuses on delivering innovative therapies to physicians and patients worldwide.
SIR-Spheres® Y-90 resin microspheres are indicated for the treatment of various liver conditions, including:
– Unresectable hepatocellular carcinoma (HCC)
– Unresectable metastatic liver tumors from primary colorectal cancer (mCRC) in patients who are refractory to or intolerant of chemotherapy
– Unresectable intrahepatic cholangiocarcinoma (iCCA)
– Hepatic metastases from neuroendocrine tumors (mNET)
– Other liver metastases
For further details on how SIR-Spheres® can be integrated into clinical practices, interested parties can reach out to Sirtex at [email protected].
This expanded approval not only enhances treatment options for liver cancer patients but also reinforces Sirtex’s commitment to innovation in the field of liver-directed interventional oncology.
