#USA #liver cancer #Woburn, Massachusetts #Sirtex Medical #SIR-Spheres

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

On July 7, 2025, Sirtex Medical announced that the U.S. Food and Drug Administration (FDA) has approved SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC). This pivotal expansion of indication positions SIR-Spheres® as the first and only radioembolization therapy authorized for both unresectable HCC and metastatic colorectal cancer (mCRC) on the liver in the United States.

Hepatocellular carcinoma is recognized as the most prevalent form of liver cancer among adults in the U.S., according to the American Cancer Society. The radioembolization procedure, commonly referred to as selective internal radiation therapy (SIRT), utilizes SIR-Spheres® to deliver a tailored dose of radiation directly to tumors in HCC patients. With this approval, clinicians have greater flexibility to select a liver-targeted therapy that aligns with individual patient needs and therapeutic goals.

Matt Schmidt, CEO of Sirtex, stated, "The extended indication makes SIR-Spheres® the sole Y-90 treatment approved in the U.S. for HCC and mCRC. This milestone reflects our ongoing commitment to providing flexible and personalized therapies — with multiple dosing options available daily — empowering physicians to treat patients at the most suitable times and locations."

This regulatory accomplishment is backed by results from the DOORwaY90 study, a prospective, multicenter, open-label clinical trial designed to assess the safety and efficacy of SIR-Spheres® in treating HCC. The trial enrolled 100 patients across 18 U.S. centers, with 65 patients included in the primary interim efficacy cohort. DOORwaY90 achieved its pre-specified co-primary endpoints, demonstrating an impressive overall response rate (ORR) of 98.5%, as evaluated by an independent central review. Notably, all evaluable patients exhibited a response, reflecting a remarkable local tumor control rate of 100%. Furthermore, the median duration of response exceeded 300 days, showcasing SIR-Spheres® as a highly effective liver therapy with a favorable safety profile.

Dr. Armeen Mahvash, an interventional radiologist at MD Anderson Cancer Center and a principal investigator of the DOORwaY90 study, commented, "This study advances the field of radioembolization thanks to reproducible dosimetric results and a strong safety profile linked to highly positive clinical outcomes. This will instill confidence in multidisciplinary care teams to recommend SIR-Spheres® for HCC treatment."

For further information and to explore how to integrate SIR-Spheres® into practice, interested parties can contact Sirtex at [email protected].

About SIR-Spheres®

SIR-Spheres® Y-90 resin microspheres from Sirtex Medical are indicated for local tumor control of unresectable hepatocellular carcinoma (HCC) in patients without macrovascular invasion, having Child-Pugh stage A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-arterial hepatic chemotherapy (IHAC) using FUDR (Floxuridine).

Disclaimer: The federal law prohibits the sale of this device by or on the order of a physician. For a complete list of indications, contraindications, side effects, warnings, and precautions, please refer to the instructions for use at www.sirtex.com/sir-spheres/risks_adverse-events.

About Sirtex

Sirtex Medical is a global healthcare company dedicated to advancing less invasive, targeted therapies for cancer and embolization predominantly involving liver interventions. With offices in the United States, Australia, Europe, and Asia, Sirtex provides innovative interventional oncology and embolization solutions to physicians and patients worldwide. The Y-90 resin microspheres, SIR-Spheres®, are currently the only product approved by the FDA for the treatment of hepatocellular carcinoma (HCC) and metastatic colorectal cancer (mCRC) in the U.S. For more information, please visit www.sirtex.com.