FDA Approves SIR-Spheres® Y-90 Microspheres for Liver Cancer Treatment

FDA Approval for SIR-Spheres® Y-90 Microspheres

In an exciting advancement in cancer treatment, Sirtex Medical has disclosed that its SIR-Spheres® Y-90 microspheres have received FDA approval for the treatment of inoperable hepatocellular carcinoma (HCC). This groundbreaking development positions SIR-Spheres® as the first and only radioembolization therapy approved in the United States for both inoperable HCC and metastatic colorectal cancer (mCRC) treatment.

According to the American Cancer Society, HCC is the most prevalent form of liver cancer among adults in the U.S. The innovative radioembolization technique, commonly referred to as selective internal radiation therapy (SIRT), employs a personalized dosimetry approach to deliver optimal radiation doses directly to the tumors in HCC patients. This approval enhances physicians' ability to select liver-targeted therapies that align with patients’ specific needs and treatment goals.

Matt Schmidt, CEO of Sirtex, emphasized the significance of this expanded indication, stating, “SIR-Spheres® now stands as the only Y-90 treatment in the U.S. approved for both HCC and mCRC. This milestone reflects our unwavering commitment to providing flexible, personalized therapies complemented by multiple daily available dosing options, allowing physicians to treat patients at the most effective times and locations.”

This pivotal regulatory achievement is substantiated by findings from the DOORwaY90 study, a prospective, multicenter, open-label clinical trial that assessed the safety and efficacy of SIR-Spheres® for treating HCC. The study involved 100 patients across 18 U.S. centers, with 65 patients included in the preliminary primary efficacy cohort. The DOORwaY90 study successfully met the predefined co-primary endpoints, demonstrating an impressive overall response rate (ORR) of 98.5% as validated through independent central review. Notably, all evaluable patients exhibited a response, indicating a remarkable 100% local tumor control rate. Additionally, the median duration of response (DoR) extended beyond 300 days, further underscoring the potential of SIR-Spheres® as an effective liver-targeted therapy with a favorable safety profile.

Dr. Armeen Mahvash, an interventional radiologist at the MD Anderson Cancer Center and co-principal investigator of the DOORwaY90 study, remarked, “This study enhances the field of radioembolization, linking reproducible dosimetry outcomes with a robust safety profile alongside very positive clinical results. This will embolden multidisciplinary treatment teams to recommend SIR-Spheres® for HCC management.”

For healthcare professionals seeking to integrate SIR-Spheres® into their practice, more information is available on contact via email at [email protected]

About SIR-Spheres®

SIR-Spheres® Y-90 microspheres are indicated for local tumor control in patients with inoperable hepatocellular carcinoma (HCC) without macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and a good performance status. Furthermore, they are indicated for the treatment of unresectable metastatic liver tumors originating from primary colorectal cancer in conjunction with hepatic artery adjuvant chemotherapy utilizing floxuridine (FUDR).

Note: According to federal law (USA), this device can only be sold by or on the order of a physician. For a complete listing of indications, contraindications, side effects, warnings, and precautions, please refer to the Instructions for Use available at www.sirtex.com/sir-spheres/risks_adverse-events.

About Sirtex Medical

Sirtex Medical is a globally recognized healthcare company specializing in the development of minimally invasive, liver-directed cancer and embolization therapies. With offices in the U.S., Australia, Europe, and Asia, Sirtex delivers innovative solutions for interventional oncology and embolization to healthcare professionals and patients worldwide. The company’s flagship product, SIR-Spheres® Y-90 microspheres, is currently the only FDA-approved product in the United States indicated for treating both hepatocellular carcinoma (HCC) and metastatic colorectal cancer (mCRC). For more information, visit www.sirtex.com.