Yttrium-90 glass microspheres
Microscopic glass beads containing a radioactive metal are injected into the artery that supplies a liver tumour. The beads stay in place permanently and give off radiation that fades away within about two weeks.
Overview
TheraSphere consists of yttrium-90 fused into glass microspheres and delivered by selective internal radiation therapy (SIRT) through a hepatic artery catheter. It was marketed in the US from 1999-2000 under a Humanitarian Device Exemption (HDE H980006) for unresectable hepatocellular carcinoma (HCC), which limited annual patient numbers.
Boston Scientific (which acquired the product from BTG/Biocompatibles) received full FDA premarket approval (PMA P200029) on 17 March 2021, based on the LEGACY study, a retrospective single-arm, multicentre study of 162 patients with solitary unresectable HCC (1-8 cm). The approved indication is SIRT for local tumour control of solitary tumours 1-8 cm in diameter in patients with Child-Pugh A cirrhosis, no macrovascular invasion and good performance status. LEGACY reported an objective response rate of 72.2% by blinded independent central review and a 76.1% six-month duration-of-response rate.
A post-approval study (multi-compartment dosimetry, MCD-HCC) is ongoing, and a further PMA supplement was cleared by FDA in February 2026. Dosing uses partition-model or MIRD dosimetry to target roughly 100 Gy to the treated liver volume; the microspheres remain permanently implanted.
1.Yttrium-90 glass microspheres slips into a pocket on its target.
- Route
- Intra-arterial infusion into the hepatic artery via catheter
- Schedule
- Single administration per treated liver territory, individualised by partition-model dosimetry aiming for a target absorbed dose
Source: www.accessdata.fda.gov/cdrh_docs/pdf20/P200029B.pdf. Doses are for orientation; the current label governs.
- Appraised for
- Unresectable advanced hepatocellular carcinoma, Child-Pugh grade A, where conventional transarterial therapies are inappropriate
- Notes
- TA688 recommends TheraSphere as an option under a commercial arrangement; QuiremSpheres was appraised in the same guidance.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA688. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2021 | Selective internal radiation therapy (SIRT) for local tumour control of solitary unresectable HCC (1-8 cm), Child-Pugh A cirrhosis, no macrovascular invasion, good performance status |
Trials
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Latest papers
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