#USA #Massachusetts #Sirtex Medical #SIR-Spheres #Y-90

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

Sirtex Medical, a leading innovator in interventional oncology, has officially announced that the U.S. Food and Drug Administration (FDA) has granted approval for its Y-90 resin microspheres, known as SIR-Spheres®. This advancement marks a significant milestone, as SIR-Spheres® is now recognized as the only radioembolization therapy authorized in the United States for both unresectable hepatocellular carcinoma (HCC) and metastatic colorectal cancer (CRC) in the liver.

Hepatocellular carcinoma (HCC) stands as the most prevalent form of liver cancer among adults in the United States, as reported by the American Cancer Society. The newly approved SIR-Spheres® Y-90 employs selective internal radiation therapy (SIRT), which personalizes dosimetry to deliver an optimal radiation dose directly to the tumors in HCC patients. This specific approval empowers physicians with greater flexibility to tailor liver-targeted therapies according to the individual needs and treatment goals of their patients.

Matt Schmidt, CEO of Sirtex, expressed his enthusiasm regarding this expanded indication, stating, "SIR-Spheres® is the only Y-90 treatment approved in the U.S. for both HCC and metastatic CRC. This milestone reflects our ongoing commitment to deliver flexible, personalized therapies, offering multiple dosing options daily, which enable physicians to treat patients effectively whenever necessary."

The regulatory achievement is backed by results from the DOORwaY90 study, a multi-center, open-label clinical trial assessing the safety and efficacy of SIR-Spheres® in treating HCC. This study examined 100 patients across 18 U.S. centers, with 65 included in the primary efficacy provisional cohort. The findings met specified co-primary evaluation criteria, demonstrating an impressive overall response rate (ORR) of 98.5%, according to independent central review assessment. Remarkably, every evaluable patient displayed a response, leading to a local tumor control rate of 100%. Furthermore, the median duration of response (DoR) exceeded 300 days, establishing SIR-Spheres® as a highly effective liver 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, underscored the significance of these results, stating, "This study propels the field of radioembolization forward, with reproducible dosimetric outcomes linked to highly positive clinical results. This will give multidisciplinary teams the confidence to recommend SIR-Spheres® for treating HCC."

For healthcare professionals looking to integrate SIR-Spheres® into their practice, additional information can be sought by contacting Sirtex directly at [email protected].

About SIR-Spheres®

SIR-Spheres® Y-90 microspheres are indicated for local tumor control of unresectable HCC in patients with no macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for treating unresectable metastatic liver tumors from primary colorectal cancer combined with intrahepatic artery radioembolization (IHAC) with floxuridine (FUDR).

Safety Warning: Federal law in the United States restricts the sale of this device to physicians or under their prescription. For a full list of indications, contraindications, side effects, warnings, and precautions, please refer to the instructions for use.

About Sirtex

Sirtex Medical is a global healthcare company focused on developing minimally invasive therapies aimed at liver cancer and embolization. With offices across the United States, Australia, Europe, and Asia, Sirtex provides innovative interventional oncology and embolization solutions to healthcare practitioners and patients worldwide. Its flagship product, SIR-Spheres® Y-90 resin microspheres, currently stands as the only FDA-approved product in the United States for treating both hepatocellular carcinoma (HCC) and metastatic colorectal cancer (CRC). For further details, please visit www.sirtex.com.