SIR-Spheres

Expanded indication makes SIR-Spheres® the first and only radioembolization therapy in the U.S. approved to treat both unresectable hepatocellular carcinoma and metastatic colorectal cancer WOBURN, Mass., July 7, 2025 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of interventional oncology solutions, today announced that the U.S. Food and Drug Administration (FDA) approved SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the United States. With this approval, SIR-Spheres® is the only radioembolization therapy approved for the treatment of both metastatic colorectal cancer (mCRC) of the liver and HCC in the U.S. HCC is the most common form of liver cancer in adults in the U.S., according to the American Cancer Society. Radioembolization–commonly referred to as selective internal radiation therapy (SIRT)–with SIR-Spheres® uses personalized dosimetry to deliver the optimal dose of radiation directly to tumors in patients with HCC. This approval gives clinicians expanded flexibility in selecting a liver-directed therapy that aligns with patient-specific needs and treatment goals. "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." This regulatory milestone is supported by results from the DOORwaY90 study, a prospective, multicenter, open-label clinical trial evaluating 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 (ORR) of 98.5% as assessed by independent central review. All evaluable patients demonstrated a response, indicating a 100% local tumor control rate. Additionally, the median duration of response (DoR) exceeded 300 days. These findings highlight SIR-Spheres® as a highly effective liver-directed therapy with a favorable safety profile. "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." For more information and details on how to incorporate SIR-Spheres® into your practice, please contact Sirtex at [email protected]. About SIR-Spheres ® SIR-Spheres® Y-90 resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine). Caution: Federal (USA) law restricts this device for sale by or on the order of a physician. Consult the Instructions for Use ( ) for a complete listing of indications, contraindications, side effects, warnings and precautions. About Sirtex Sirtex Medical is a global healthcare company focused on advancing minimally invasive, liver-directed cancer and embolization therapies. With offices in the U.S., Australia, Europe, and Asia, Sirtex delivers innovative interventional oncology and embolization solutions to physicians and patients worldwide. The company's lead product, SIR-Spheres® Y-90 resin microspheres, is now the only FDA approved product in the United States indicated for both the treatment of hepatocellular carcinoma (HCC) and metastatic colorectal cancer (mCRC). For more information, visit . APM-US-010-06-25 SOURCE Sirtex Medical Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Sirtex brings an innovative liver cancer treatment delivery system to Europe, enhancing options for physicians and their patients. WOBURN, Mass., Sept. 16, 2024 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of interventional treatment solutions, today announced that it has received certification according to Medical Device Regulation (EU) 2017/745 for SIR-Spheres® Y-90 resin microspheres and its delivery systems, paving the way for the European launch of the SIROS™ Delivery System. The EU MDR places greater emphasis on patient safety measures, risk management, post-market surveillance, and comprehensive data collection for medical devices seeking European market access. "Patient health and safety are always at the forefront of our work. That is why we are particularly proud to receive EU MDR certification for SIR-Spheres® Y-90 resin microspheres and its delivery systems, including SIROS™. This achievement underscores our commitment to delivering innovative products responsibly and ethically," said Matt Schmidt, CEO of Sirtex Medical Inc. "With the expansion of SIROS™ outside of the U.S., interventional radiologists in Europe now have an additional option to support patients battling metastatic colorectal cancer (mCRC) and unresectable hepatocellular carcinoma (HCC). This milestone reflects the outstanding efforts of our team, the rapid growth of our business, and the groundbreaking interventional oncology solutions we have developed." The SIROS™ Delivery System offers an intuitive, visual, and adaptable solution for physicians to administer SIR-Spheres® to liver cancer patients. Its easy-to-use design along with controlled administration provides physicians confidence in the Y-90 delivery. "As an interventional radiologist, I am excited about the future use of the SIROS™ Delivery System," shared Professor Thomas Helmberger, Head of Department of Radiology, Neuroradiology, and Minimal-Invasive Therapy at München Klinik Bogenhausen in Munich, Germany. "This device has an intuitive design and a precise control that will facilitate the administration of SIR-Spheres® Y-90 resin microspheres, and I am looking forward to incorporating it into my practice." About SIR-Spheres® in Europe SIR-Spheres® are medical devices used in selective internal radiation therapy (SIRT) and are indicated for the treatment of unresectable hepatocellular carcinoma (HCC) and unresectable metastatic liver tumors from primary colorectal cancer (mCRC) in patients refractory to or intolerant of chemotherapy. For a complete listing of indications, contraindications, side effects, warnings, and precautions, please consult the Instructions for Use at . About Sirtex Sirtex is a global healthcare company with offices in the U.S., Australia, Europe, and Asia, dedicated to improving patients' quality of life and longevity through innovative, minimally invasive cancer and embolization therapies. Sirtex's current leading product, SIR-Spheres® Y-90 resin microspheres, offers targeted radiation therapy for liver cancer. For more information, visit . SOURCE Sirtex Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED