#USA #liver cancer #Woburn #Sirtex Medical #SIR-Spheres Y-90

Sirtex Medical Achieves FDA Approval for SIR-Spheres® Y-90.

On July 7, 2025, Sirtex Medical, a key player in interventional oncology, announced an important milestone: the U.S. Food and Drug Administration (FDA) has approved its SIR-Spheres® Y-90 resin microspheres for the treatment of non-surgical hepatocellular carcinoma (HCC). This approval positions SIR-Spheres® as the first and only radioembolization therapy authorized in the U.S. for both non-resectable HCC and metastatic colorectal cancer (mCRC) in the liver.

The Impact of FDA Approval

According to the American Cancer Society, HCC is the most common form of liver cancer among adults in the U.S., making effective treatment options critical. Radioembolization, commonly referred to as Selective Internal Radiation Therapy (SIRT), utilizes SIR-Spheres® to deliver a personalized radiation dose directly to tumors in patients with HCC, allowing doctors to cater the treatment to individual patient needs and therapy goals.

Matt Schmidt, CEO of Sirtex, stated, "With the expanded indications, SIR-Spheres® have become the only Y-90 therapy approved in the U.S. for both HCC and mCRC. This milestone reflects our ongoing commitment to providing flexible, personalized therapies with multiple dosing options available routinely, enabling doctors to treat patients at optimal times and locations."

Clinical Evidence Supporting Approval

The regulatory achievement is backed by the results from the DOORwaY90 study, a prospective, multi-center open-label clinical trial assessing the safety and efficacy of SIR-Spheres® for treating HCC. The trial included 100 patients across 18 centers in the U.S., with 65 patients in the pivotal efficacy cohort. The DOORwaY90 trial achieved its predetermined co-primary endpoints, demonstrating an impressive overall response rate (ORR) of 98.5%, per the assessment by an independent central review committee (ICR). Every patient evaluated responded to the treatment, indicating a 100% effectiveness rate in combating localized tumors, with a median duration of response (DoR) exceeding 300 days. These results highlight the high efficacy of SIR-Spheres® in treating liver cancers and its favorable safety profile.

Dr. Armeen Mahvash, interventional radiologist at the MD Anderson Cancer Center and one of the study's principal investigators, remarked, "This study represents a step forward in radioembolization with reproducible dosimetry outcomes and a robust safety profile linked to highly positive clinical results. Thus, multidisciplinary teams can confidently recommend SIR-Spheres® for HCC treatment."

How to Incorporate SIR-Spheres® into Practice

For additional information and details on how to integrate SIR-Spheres® into clinical practice, healthcare providers can contact Sirtex through their website or directly at [email protected].

SIR-Spheres® Y-90 resin microspheres are indicated for the local control of tumor in non-resectable HCC for patients without macrovascular invasion, Child-Pugh class A cirrhosis, and good liver function and performance status. They are also indicated for treating unresectable secondary liver tumors following metastasis from primary colorectal cancer, in conjunction with adjuvant chemotherapy using FUDR administered via the hepatic artery (IHAC).

It is important to note that U.S. federal law restricts the sale of this product by or on the order of a physician. A complete list of indications, contraindications, adverse effects, warnings, and precautions can be found in the instructions for use on their official website (www.sirtex.com/sir-spheres/risks_adverse-events).

About Sirtex Medical

Sirtex Medical is a global healthcare company focused on developing minimally invasive therapies for liver tumor treatments and embolization. Operating in the U.S., Australia, Europe, and Asia, Sirtex provides innovative interventional oncology and embolization solutions to healthcare providers and patients worldwide. The company’s flagship product, SIR-Spheres® Y-90, is currently the only FDA-approved product in the United States indicated for both hepatocellular carcinoma (HCC) and metastatic colorectal cancer (mCRC). To learn more, visit www.sirtex.com.

APM-US-010-06-25