FDA Approves Sirtex Medical's SIR-Spheres® Y-90 for Cancer Treatment in the U.S.

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

In a significant advancement in cancer treatment, the U.S. Food and Drug Administration (FDA) has granted approval for Sirtex Medical's SIR-Spheres® Y-90, a radiotherapy option for patients suffering from unresectable hepatocellular carcinoma (HCC). This landmark decision places SIR-Spheres® Y-90 as a leading radioembolization treatment in the U.S., not only for HCC but also for metastatic colorectal cancer (mCRC) affecting the liver.

According to the American Cancer Society, HCC is the most common type of liver cancer in adults within the United States, and patients with this condition often face limited treatment options. The recently approved SIR-Spheres® Y-90 employs a personalized dosimetry approach providing targeted radiation directly to tumors. This innovative method enhances treatment flexibility, allowing physicians to tailor protocols based on individual patient needs.

Matt Schmidt, CEO of Sirtex, highlighted that this expanded approval underscores their commitment to delivering flexible and personalized treatment options. “With the broader indication, SIR-Spheres® stands out as the sole Y-90 treatment approved in the U.S. for both HCC and mCRC,” he stated. “This milestone reflects our ongoing dedication to ensuring physicians have multiple dosing options available daily, enabling them to treat patients with maximum efficacy.”

The regulatory milestone is reinforced by results from a significant clinical study named DOORway90. This prospective, multicenter, open-label trial evaluated the safety and efficacy of SIR-Spheres® in treating HCC. The study involved 100 patients across 18 centers in the U.S., with 65 patients included in the primary efficacy group. Impressively, the study met its pre-defined primary endpoints, showcasing a remarkable overall response rate (ORR) of 98.5%, according to an independent central review. Notably, there was a 100% local tumor control rate among all evaluable patients, alongside a median duration of response exceeding 300 days.

Dr. Armeen Mahvash, a leading interventional radiologist from the MD Anderson Cancer Center and one of the principal investigators of the DOORway90 study, praised the findings: “This study marks progress in radioembolization through reproducible dosimetric outcomes and a strong safety profile, in conjunction with very positive clinical results. It provides multidisciplinary healthcare teams with the confidence to recommend SIR-Spheres® in the management of HCC.”

SIR-Spheres® Y-90 is indicated for the local control of unresectable HCC tumors in patients without macrovascular invasion, classified as Child-Pugh Class A with well-compensated liver function. Moreover, it is approved for treating unresectable liver metastases arising from primary colorectal cancer in conjunction with adjuvant intrahepatic arterial chemotherapy using floxuridine (FUDR).

For medical professionals seeking to integrate SIR-Spheres® into their practice, additional information can be obtained by contacting Sirtex at [email protected]

About Sirtex Medical

Sirtex Medical is a global healthcare company focused on developing minimally invasive cancer treatment procedures and embolic therapies. With operations in the USA, Australia, Europe, and Asia, Sirtex offers innovative solutions in interventional oncology to doctors and patients worldwide. The primary product, SIR-Spheres® Y-90, is currently the only FDA-approved product in the United States indicated for the treatment of both HCC and mCRC. More information can be found at www.sirtex.com.