Extended indication makes SIR-Spheres® For the first and only radioembolization therapy in the United States, which is approved for the treatment of inoperable liver cell carcinoma and metastatic intestinal cancer
Sirtex Medical („Sirtex”)a leading manufacturer of interventional oncology solutions, announced today that the US Food and Drug Administration (FDA) Sir-Spheres® Y-90 Harz Mikrosphere approved for the treatment of inoperable Hepatocellular carcinoma (HCC) in the United States. With this approval, SIR-Spheres® is the only radio embolization therapy that is approved in the United States for the treatment of metastatic colon cancer (MCRC) in the liver and HCC.
HCC is the most common form of liver cancer in adults in the USA, such as the American Cancer Society communicated. Radioembolization-generally referred to as selective internal radiation therapy (Sirt)-uses Sir-Spheres® to use personalized dosimetry to provide the optimal radiation dose directly to the tumor of patients with HCC. This approval offers doctors more flexibility when choosing a therapy geared towards the liver, which is tailored to the specific needs and treatment goals of the patient.
“The extended indication makes SIR-Spheres® the only Y-90 treatment that is approved in the USA for both HCC and MCRC,” said Matt Schmidt, Managing Director of Sirtex. “This milestone reflects our continuous commitment to the provision of flexible, personalized therapies – with several daily dosage options available daily – that enable doctors to treat patients when and where it works best.”
This regulatory milestone is supported by the results of the Doorway90 study, a prospective, multicenter, open clinical study to evaluate the security and effectiveness of SIR-Spheres® in the treatment of HCC. 100 patients from 18 US centers took part in the study, with 65 patients being included in the preliminary primary effectiveness cohort. Doorway90 has reached the predefined co-primary endpoints and showed a best overall response rate (ORR) of 98.5 %, which was determined by an independent central review. All evaluable patients showed an response that indicates a 100%local tumor control rate. In addition, the middle response time (DOR) was over 300 days. These results underline SIR-Spheres® as a highly effective therapy aimed at the liver with a cheap safety profile.
“This study provides the area of radio embolization with reproducible dosimetry results and a strong security profile in conjunction with very positive clinical results,” said Dr. Army Mahvash, intervention radiologist at the MD Anderson Cancer Center and Co-Princal Investigator of the Doorway90 study. “This will give the multidisciplinary treatment teams to recommend SIR-Spheres® for HCC treatment.”
For more information and details about how you can integrate SIR-Spheres® into your practice, please contact Sirtex by email by email: info-use@sirtex.com.
Information on SIR-Spheres ®
SIR-Spheres® Y-90 Harz Mikrospheres are indicated for local tumor control of the inoperable hepato cellular carcinoma (HCC) in patients without macrovascular invasion, with child-puh-a cirrhosis, well-compensated liver function and good performance status. They are also displayed for the treatment of inoperable metastatic liver tumors with primary colorectal carcinoma with adjuvant chemotherapy in liver artery (IHAC) with FUDR (floxuridine).
Note: According to the Federal Law (USA), this device may only be sold by a doctor or on the order. In the instructions for use ( www.sirtex.com/sir-spheres/risks_adverse-events) Find a complete list of the indications, contraindications, side effects, warnings and precautions.
Information on Sirtex Sirtex Medical is a worldwide healthcare company that focuses on the development of minimally invasive, the liver directed cancer and embolization therapies. With branches in the USA, Australia, Europe and Asia, Sirtex provides innovative solutions for interventional oncology and embolization to doctors and patients worldwide. The main product of the company, Sir-Spheres® Y-90 Harz-Mikrosphere, is currently the only product approved by the FDA in the United States that is indicated for the treatment of liver cell carcinoma (HCC) and metastatic colorectal carcinoma (MCRC). You can find more information on www.sirtex.com.
APM-US-010-06-25
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