#USA #Woburn #Hepatocellular Carcinoma #Sirtex Medical #Y-90 SIR-Spheres

FDA Approval for Y-90 SIR-Spheres® by Sirtex Medical

On July 7, 2025, Sirtex Medical, a leader in interventional oncology products, announced that the U.S. Food and Drug Administration (FDA) has granted approval for its Y-90 SIR-Spheres® resin microspheres. This treatment is designated for patients suffering from unresectable hepatocellular carcinoma (HCC) and represents a significant milestone in targeted cancer therapies. The SIR-Spheres® are now the first and only radioembolization therapy approved in the United States for both unresectable HCC and metastatic colorectal carcinoma (mCRC) affecting the liver.

The approval comes at a time when liver cancer continues to surge in prevalence, with HCC being the most common type of liver cancer in adults in the United States, as reported by the American Cancer Society. Radioembolization, often referred to as Selective Internal Radiation Therapy (SIRT), employs SIR-Spheres® to deliver personalized dosimetry, allowing for an optimal radiation dose directly to the tumors in HCC patients. This new approval allows physicians to offer a tailored liver-targeted therapy to meet their patients' unique treatment goals and needs.

Matt Schmidt, CEO of Sirtex, mentioned, "The extended indication makes SIR-Spheres® the only Y-90 treatment approved in the U.S. for both HCC and mCRC. This milestone reflects our ongoing commitment to delivering flexible, personalized treatment options that enable physicians to treat patients effectively, right where and when it works best."

Furthermore, this regulatory achievement is backed by the results from the DOORwaY90 study, a prospective, multicentric, open-label clinical trial that evaluated the safety and efficacy of SIR-Spheres® in the treatment of HCC. The study enrolled 100 patients from 18 different centers in the United States, with 65 patients included in the preliminary primary efficacy cohort. The DOORwaY90 trial met its predetermined primary endpoint benchmarks and demonstrated an impressive overall response rate of 98.5%, as assessed by independent central review. Astoundingly, every assessed patient showed a tumor response, illustrating a remarkable 100% rate of local control. Additionally, the median duration of response exceeded 300 days, indicating that SIR-Spheres® are a highly effective liver-targeted therapy with a favorable safety profile.

Dr. Armeen Mahvash, an interventional radiologist at MD Anderson Cancer Center and co-investigator of the DOORwaY90 study, stated, "This study advances the field of radioembolization through reproducible dosimetry results and a strong safety profile associated with very positive clinical outcomes. This will give multidisciplinary care teams confidence in recommending SIR-Spheres® therapy for HCC treatment."

For further information about incorporating SIR-Spheres® into clinical practice, Sirtex can be contacted at [email protected].

About SIR-Spheres®

Y-90 SIR-Spheres® resin microspheres are indicated for localized tumor control of unresectable hepatocellular carcinoma (HCC) in patients without macrovascular invasion, with Child-Pugh Class A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for treating surgical unresectable metastatic liver tumors from primary colorectal cancer with adjunctive intrahepatic arterial chemotherapy (IHAC) with FUDR (floxuridine).

Disclaimer: Federal law in the USA restricts the sale of this device to licensed physicians or on their order. A complete list of indications, contraindications, adverse effects, warnings, and safety precautions can be found in the product's instructions for use at www.sirtex.com/sir-spheres/risks_adverse-events.

About Sirtex Medical

Sirtex Medical is a global healthcare company focused on developing minimally invasive cancer treatment and liver embolization solutions. With branches in the U.S., Australia, Europe, and Asia, Sirtex provides innovative interventional oncology and embolization products to doctors and patients worldwide. The company's flagship product, Y-90 SIR-Spheres®, is now the only FDA-approved product in the U.S. for treating both hepatocellular carcinoma (HCC) and metastatic colorectal carcinoma (mCRC). For more information, visit www.sirtex.com.