FDA approves revolutionary therapy against liver cancer in the USA!

FDA approves revolutionary therapy against liver cancer in the USA!

USA - On July 7, 2025, Sirtex Medical receives the FDA approval for the SIR-Spheres® Y-90 Harz Mikrospheres. This represents significant progress in the treatment of inoperable hepato cellular carcinoma (HCC) and metastatic colon cancer (MCRC). With this approval, SIR-Spheres® is the first and only radioembolization therapy that was recognized in the USA for these indications, such as Oots.at reported.

hepatocellular carcinoma is the most common form of liver cancer in adults in the USA. The therapy uses a personalized dosimetry to specifically deliver the radiation dose directly to the tumor in the liver tissue. This innovative approach enables doctors to tune their treatment strategies more flexibly to the specific needs of their patients.

results and studies

The admission was supported by the Doorway90 study, a multicenter clinical study that included 100 patients from 18 US centers. This study achieved an impressive overall response rate of 98.5 % and a local tumor control rate of 100 %. The middle response time was over 300 days. The SIR-SPHERES® are approved for patients without macrovascular invasion, a child-Pugh-A-cirrhosis status and a well-compensated liver function. The product is also permitted for inoperable metastatic liver tumors with primary colorectal carcinoma in combination with adjuvant chemotherapy.

In the past two decades, inert microspheres have been developed with radionuclides for selective intrahepatic radiotherapy (Sirt). This technique aims to hand over high radiation doses directly at liver tumors by injecting the microspheres into the liver capillaries via the liver artery. As described in pmc.ncbi.nih.gov Blood can be treated, which enables targeted treatment and minimizes the radiation exposure to the non-tumorous liver tissue.

therapeutic alternatives and future developments

The updated S3 guideline for hepatocellular and biliary carcinomas recommends Sirt as an alternative therapy for transarterial chemoembolization for patients with surviving liver function in the early and intermediate stage. These approaches have proven to be effective through new studies, including the dosisphere and legacy study. The studies show high objective response rates and a very good, permanent tumor control in patients under Sirt, such as aerzentzeitung.de determined.

These developments in the therapy of liver cancer mark significant progress in oncology and help to improve the survival rates and quality of life of the patients while promoting personalized treatment approaches.