[90Y]Y-microsphere

Compound class

Yttrium-90 microspheres (radioembolization microspheres)

Target / mechanism

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Clinical application

Selective internal radiation treatment (SIRT) / transarterial radioembolization for liver tumours (primary and metastatic liver cancer) PMID 24036875

Theranostic pair

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FDA

Medical-device approval (PMA), not a drug NDA/BLA — SIR-Spheres Y-90 resin microspheres (Sirtex Medical, Inc.), PMA P990065, original approval 2002-03-05; TheraSphere Y-90 glass microspheres (Boston Scientific Corporation), PMA P200029, original approval 2021-03-17. Register generic name: 'Microspheres radionuclide' FDA device PMA register via openFDA: https://api.fda.gov/device/pma.json?search=pma_number:%22P990065%22 ; https://api.fda.gov/device/pma.json?search=pma_number:%22P200029%22 (queried 2026-09-18); no drug application (NDA/BLA) for microspheres in openFDA Drugs@FDA

EMA (centralised)

No — no centrally authorised medicine (CE-marked device status was not checked) EMA medicines register (JSON export 2026-09-18): no yttrium (90Y) microsphere / SIR-Spheres / TheraSphere entry

Other approvals

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Brand names

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Clinical studies in the indexed corpus, ordered by design (multicentre, prospective, retrospective, others, case reports last) and then by year. Titles and links only, as published; this is not a summary of the evidence.

1. Transarterial Radioembolisation with Y90 Resin Microspheres and the Effect of Reimbursement Criteria in France: Final Results of the CIRT-FR Prospective Observational Study.
   2025 · Cardiovasc Intervent Radiol · Prospective, multicentre
2. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials.
   2017 · Lancet Oncol · Multicentre · Phase III
3. Radioembolisation with yttrium‒90 microspheres versus sorafenib for treatment of advanced hepatocellular carcinoma (SARAH): study protocol for a randomised controlled trial.
   2014 · Trials · Prospective, multicentre
4. Aspartate Aminotransferase to Platelet Index (APRI) as a Prognostic Factor for Overall Survival After TARE Y90 Resin Microspheres in Primary Liver Cancer Patients: Results from the European, Prospective Observational Study CIRT.
   2026 · Cardiovasc Intervent Radiol · Prospective
5. The predictive value of 18F-FAPI PET/CT and voxel-based tumor absorbed dose for the response and clinical outcome of unresectable hepatocellular carcinoma patients treated with Yttrium-90 resin microsphere selective internal radiation therapy.
   2026 · Eur J Nucl Med Mol Imaging · Prospective
6. Urinary Excretion of Yttrium-90 after Radioembolization with Yttrium-90-Labeled Resin-based Microspheres.
   2018 · Health Phys · Prospective
7. Prospective, randomized study of coil embolization versus Surefire infusion system during yttrium-90 radioembolization with resin microspheres.
   2014 · J Vasc Interv Radiol · Prospective
8. Personalized dosimetry enhances hepatocellular carcinoma response in Yttrium-90 resin microsphere radioembolization.
   2026 · Eur Radiol · Retrospective
9. Histopathologic analysis of intrahepatic cholangiocarcinoma treated with transarterial radioembolization using Yttrium-90 resin microspheres.
   2026 · Eur J Nucl Med Mol Imaging · Retrospective
10. Histopathologic outcomes of hepatocellular carcinoma treated with transarterial radioembolization with yttrium-90 resin microspheres.
    2026 · Eur J Nucl Med Mol Imaging · Retrospective