What year was Yttrium-90 (Y-90) therapy approved by the Food and Drug Administration (FDA)?

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From the Research

Yttrium-90 (Y-90) radioembolization therapy was approved by the FDA in 2002 for the treatment of unresectable hepatocellular carcinoma (liver cancer) and liver metastases from colorectal cancer. The approval specifically covered TheraSphere and SIR-Spheres, which are the two main Y-90 products used in clinical practice. Y-90 therapy works by delivering microscopic radioactive glass or resin beads directly to liver tumors through the hepatic artery, where they become lodged in the tumor's blood vessels. The radioactive yttrium-90 isotope then emits beta radiation that penetrates only a few millimeters into the surrounding tissue, delivering a high radiation dose to the tumor while sparing healthy liver tissue. This targeted approach allows for higher radiation doses than would be possible with external beam radiation therapy. Since its initial approval, the indications for Y-90 therapy have expanded to include other types of primary and metastatic liver cancers, making it an important option in the treatment arsenal for patients with liver malignancies, as discussed in recent studies 1. Some of the key benefits of Y-90 therapy include its ability to downstage large tumors, making them eligible for transplantation, and its use as a palliative therapy for patients with advanced disease, as noted in studies such as 2 and 3. However, it is essential to carefully select patients for this treatment and to monitor them closely for potential side effects, such as nausea, fatigue, and abdominal pain, as highlighted in studies like 4 and 5. Overall, Y-90 radioembolization therapy is a valuable treatment option for patients with liver cancer, offering a targeted and effective approach to managing this complex disease.

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