Sirtex Medical announced that the U.S. Food and Drug Administration has approved SIR-Spheres Y-90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC), establishing it as the first and only radioembolization therapy in the United States approved to treat both HCC and metastatic colorectal cancer of the liver.
The approval addresses a significant clinical need, as HCC represents the most common form of liver cancer in adults in the U.S., according to the American Cancer Society. The radioembolization therapy, commonly referred to as selective internal radiation therapy (SIRT), uses personalized dosimetry to deliver optimal radiation doses directly to tumors in HCC patients.
Clinical Trial Results Drive Approval
The regulatory milestone is supported by results from the DOORwaY90 study, a prospective, multicenter, open-label clinical trial that evaluated the safety and efficacy of SIR-Spheres in treating HCC. The study enrolled 100 patients across 18 U.S. centers, with 65 patients included in the interim primary efficacy cohort.
DOORwaY90 met its prespecified co-primary endpoints, demonstrating a best overall response rate of 98.5% as assessed by independent central review. Notably, all evaluable patients demonstrated a response, indicating a 100% local tumor control rate. The median duration of response exceeded 300 days, highlighting the therapy's sustained effectiveness.
"This study moves the field of radioembolization forward with reproducible dosimetry outcomes and a strong safety profile linked to very positive clinical results," said Dr. Armeen Mahvash, Interventional Radiologist at MD Anderson Cancer Center and Co-Principal Investigator of the DOORwaY90 Study. "This will give multidisciplinary care teams the confidence to recommend SIR-Spheres for HCC treatment."
Expanded Treatment Options
The approval provides clinicians with expanded flexibility in selecting liver-directed therapies that align with patient-specific needs and treatment goals. SIR-Spheres Y-90 resin 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.
"The expanded indication makes SIR-Spheres the only Y-90 treatment approved in the U.S. for both HCC and mCRC," said Matt Schmidt, CEO of Sirtex. "This milestone reflects our ongoing commitment to delivering flexible, personalized therapies—with multiple dose options available daily—that empowers physicians to treat patients when and where it works best."
About the Technology
SIR-Spheres Y-90 resin microspheres are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy of FUDR (Floxuridine). The therapy represents a minimally invasive approach to liver-directed cancer treatment, utilizing targeted radiation delivery to maximize therapeutic benefit while minimizing systemic exposure.
Sirtex Medical, a global healthcare company with offices in the U.S., Australia, Europe, and Asia, focuses on advancing minimally invasive, liver-directed cancer and embolization therapies. The company delivers innovative interventional oncology and embolization solutions to physicians and patients worldwide.
