#USA #Woburn #Hepatocellular Carcinoma #Sirtex Medical #SIR-Spheres

Sirtex Medical's SIR-Spheres® Y-90 Microspheres Approved for HCC

Sirtex Medical has announced a major advancement in cancer treatment with the FDA's recent approval of their SIR-Spheres® Y-90 resin microspheres specifically for patients suffering from unresectable hepatocellular carcinoma (HCC). This groundbreaking decision represents a pivotal moment for the field of interventional oncology, as it positions SIR-Spheres® as the only radioembolization therapy in the United States approved for treating both unresectable HCC and metastatic colorectal cancer (mCRC).

Significance of the Approval

According to the American Cancer Society, HCC is the most prevalent form of liver cancer among adults in the U.S. The innovative radioembolization technique, often referred to as selective internal radiation therapy (SIRT), allows for a tailored approach to treatment. It utilizes personalized dosimetry to direct radiation precisely to liver tumors in HCC patients. This flexibility enables healthcare professionals to select therapeutic interventions that align with the unique requirements and treatment objectives of each patient.

Matt Schmidt, the CEO of Sirtex, expressed enthusiasm, stating, "The expanded indication makes SIR-Spheres® the only Y-90 treatment approved in the U.S. for both HCC and mCRC. This milestone reflects our ongoing commitment to delivering flexible, personalized therapies—empowering physicians to effectively treat patients when and where it suits them best."

Research Backing

This regulatory achievement is supported by findings from the DOORwaY90 study, a prospective, multicenter, open-label clinical trial aimed at evaluating the safety and efficacy of SIR-Spheres® in treating HCC. Encompassing 100 patients from 18 centers across the U.S., the study highlighted remarkable results, including a best overall response rate (ORR) of 98.5%. Notably, all evaluable patients showed a response, indicating a 100% local tumor control rate, with the median duration of response exceeding 300 days. The compelling outcomes underscore the effectiveness of SIR-Spheres® as a highly reliable, liver-directed therapy that maintains a favorable safety profile.

Dr. Armeen Mahvash, an Interventional Radiologist at MD Anderson Cancer Center and Co-Principal Investigator of the DOORwaY90 study, stated, "This study advances the field of radioembolization, providing reproducible dosimetry outcomes linked to strong safety and outstanding clinical results. This empowers multidisciplinary care teams to confidently integrate SIR-Spheres® into HCC treatment protocols."

About SIR-Spheres®

SIR-Spheres® Y-90 resin microspheres are specifically indicated for localized tumor control of unresectable hepatocellular carcinoma in patients without macrovascular invasion, those with Child-Pugh A cirrhosis, well-compensated liver function, and good performance status. Additionally, they are indicated for treating unresectable metastatic liver tumors originating from primary colorectal cancer, used alongside intra-hepatic artery chemotherapy of FUDR (Floxuridine).

As per federal regulations, the sale of this device is restricted to physicians or their orders, with additional information and guidance available through the Instructions for Use provided by Sirtex.

About Sirtex Medical

Sirtex Medical is a global healthcare company dedicated to advancing minimally invasive, liver-directed cancer therapies. With a presence in regions including the U.S., Australia, Europe, and Asia, Sirtex aims to deliver innovative oncology and embolization solutions to healthcare professionals and patients worldwide. The company's flagship product, SIR-Spheres® Y-90 resin microspheres, now holds the distinction of being the sole FDA-approved treatment in the U.S. for both hepatocellular carcinoma and metastatic colorectal cancer. For further details, interested parties can visit www.sirtex.com.