#USA #Woburn #Sirtex Medical #SIR-Spheres #Y-90 Microspheres

Sirtex Expands Treatment Options with New CE Mark Approval for SIR-Spheres®

In a significant regulatory development for cancer treatment, Sirtex Medical has secured expanded CE Mark approval for its innovative SIR-Spheres® Y-90 resin microspheres. This move broadens the eligibility criteria for patients suffering from liver cancer throughout Europe and other CE-marked regions. With the new endorsement, the treatment is now applicable to both primary liver tumors and secondary liver metastases, enhancing access to an already recognized, targeted therapy.

A Step Forward in Cancer Care

The CEO of Sirtex, Matt Schmidt, highlighted the importance of this achievement, 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 expanded approval means that more patients can now leverage the potential benefits of SIR-Spheres®, a treatment that is reportedly well-tolerated and effective when administered at critical junctures in their health journey.

Radioembolization, often referred to as selective internal radiation therapy (SIRT), is a specialized technique that delivers radioisotope yttrium-90 directly into tumors via the hepatic artery. This targeted approach allows for high dosage radiation while limiting damage to surrounding healthy tissue, a crucial factor in cancer treatment.

Clinically Supported Therapy

The clinical effectiveness of Y-90 radioembolization has been well-documented in treating multiple sophisticated liver tumors. Professor Dr. Jens Ricke, the Director at the Clinic and Polyclinic of Radiology at the Munich-based University Hospital Ludwig-Maximilians, remarked on its clinical value: "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."

This expansion by Sirtex follows rigorous assessments of clinical data affirming the safety and effectiveness of SIR-Spheres® across a variety of liver metastases. The recent approval from the FDA for SIR-Spheres® in the United States for unresectable hepatocellular carcinoma (HCC) further solidifies its standing as a versatile treatment option on a global scale.

What This Means for Patients

For European patients and healthcare providers, this CE Mark expansion signifies a vital tool in the management of liver cancers, where limited options exist. Specifically, SIR-Spheres® is now indicated for:

• - Unresectable hepatocellular carcinoma (HCC),
• - Unresectable metastatic liver tumors stemming from primary colorectal cancer (mCRC) in patients who are refractory to or intolerant of chemotherapy,
• - Unresectable intrahepatic cholangiocarcinoma (iCCA),
• - Hepatic metastases due to neuroendocrine tumors (mNET),
• - Other liver metastases.

As treatments for cancer continue to evolve, the importance of innovation in medical technologies cannot be understated. Sirtex’s commitment to liver-directed interventional oncology is underscored by their dedication to advancing solutions that provide meaningful outcomes for patients worldwide.

Sirtex Medical, which operates globally with offices in the United States, Australia, Europe, and Asia, seeks to deliver state-of-the-art embolization techniques to both physicians and patients. More information about SIR-Spheres® and how to implement this treatment into clinical practices can be obtained by contacting Sirtex directly or visiting their official website.

Conclusion

As the fight against liver cancer continues, developments like the expanded CE Mark approval for SIR-Spheres® Y-90 resin microspheres represent progress and hope in interventional oncology. With more patients potentially benefitting from this treatment, Sirtex Medical reaffirms its role as a pivotal player in the battle against liver cancer, encouraging both healthcare providers and patients to explore new possibilities for treatment.