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Internal view of patient's torso demonstrating targeted accuracy of TheraSphere Y-90 Glass Microspheres in liver.

TheraSphere™ Y-90 Glass Microspheres

Clinical data

Most studied Y-90 HCC therapy

TheraSphere Y-90 Glass Microspheres are a proven, evidence-based HCC therapy that hits tumors hard. Now you have the power to reliably shrink and destroy tumors and enhance outcomes.

  • TheraSphere’s 20+ year legacy is backed by significant investments in clinical evidence with more than 100,000 patient treatments globally.
  • With clinical studies enrolling more than 2,000 patients worldwide, TheraSphere has demonstrated success in improving tumor response and extending patient survival.

Dosimetry Steering Committee recommendations

Key updates from an international multidisciplinary working group include dosing recommendations based on contemporary clinical data, including TheraSphere landmark studies LEGACY, TARGET and DOSISPHERE-01 Trial.

5 treatment scenarios of therasphere

93% OS

Overall Survival rate in patients with transplant or resection following TheraSphere at 3 years in the LEGACY study.1

26.6 months

Overall survival in patients with advanced HCC who received TheraSphere in the DOSISPHERE-01 study using multicompartment dosimetry.2

20.3 months

Median overall survival after the use of TheraSphere for HCC in the TARGET study, demonstrating efficacy in this patient population and predictable clinical outcomes.3


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BCLC guidelines

Updated Barcelona Clinic Liver Cancer (BCLC) guidelines for HCC now include Transarterial Radioembolization (TARE/Y-90) for very early stage (0) and early stage (A) patients.⁴ These guidelines influence clinical decision-making and are based on the LEGACY Study results.

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20+ years of success in HCC treatment

Impact

TheraSphere clinical data stat - 500+ publications in peer-reviewed journals.

New evidence

TheraSphere clinical data stat - 100 global investigator-initiated studies

Major clinical programs

TheraSphere clinical data stat - 100,000+ patient treatments globally.

Untitled Document
TheraSphere vial image
  • 1999 TheraSphere receives FDA HDE approval
  • 2004 Advanced HCC with or without PVT5
  • 2006 Downstaging and bridging to transplant6
  • 2009 Radiation lobectomy: local tumor shrinkage and hypertrophy of normal liver7
  • 2011 Radiation segmentectomy: high-dose radiation delivered to ≤ 2 hepatic segments8
  • 2014
    Radiation segmentectomy threshold
    dose >190 Gy9
  • 2018 Curative intent: early HCC and low tumor burden10
  • 2020 Legacy confirms neoadjuvant or standalone treatment in HCC12 Dosisphere-01 personalized dosimetry approach improves overall survival11
  • 2021 PMA: 1st and only Y-90 therapy approved by FDA for HCC
  • 2021 Target: global real-world study confirms tumor absorbed dose is critical for predictable tumor response and OS in broad population3
  • 2021 BCLC Guidelines: LEGACY study led to inclusion of TARE for very early and early-stage unresectable HCC4
  • 2022 RASER Prospective study assessing radiation segmentectomy using TheraSphere Y-9013

1999: TheraSphere receives FDA HDE approval • 2004: Advanced HCC with or without PVT 52006: Downstaging and bridging to transplant 62009: Radiation lobectomy: local tumor shrinkage and hypertrophy of normal liver 72011: Radiation segmentectomy: high-dose radiation delivered to ≤ 2 hepatic segments 82014: Radiation segmentectomy threshold dose >190 Gy 92018: Curative intent: early HCC and low tumor burden 102020: Legacy confirms neoadjuvant or standalone treatment in HCC 12 Dosisphere-01 personalized dosimetry approach improves overall survival 11 2021: PMA: 1st and only Y-90 therapy approved by FDA for HCC • 2021: Target: global real-world study confirms tumor absorbed dose is critical for predictable tumor response and OS in broad population 32021: BCLC Guidelines: LEGACY study led to inclusion of TARE for very early and early-stage unresectable HCC 42022: RASER Prospective study assessing radiation segmentectomy using TheraSphere Y-90 13

References

  1. Salem R, Johnson GE, Kim E, Riaz A, Bishay V, Boucher E, Fowers K, Lewandowski R, Padia SA. Yttrium-90 Radioembolization for the Treatment of Solitary, Unresectable Hepatocellular Carcinoma: The LEGACY Study. Hepatology. 2021 Mar 19. doi: 10.1002/hep.31819.
  2. Garin E, Tselikas L, Guiu B et al. Personalized versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial. Lancet Gastroenterol Hepatol. 2021, 6: 17-29
  3. Lam, M., Garin, E., Maccauro, M. et al. A global evaluation of advanced dosimetry in transarterial radioembolization of hepatocellular carcinoma with Yttrium-90: the TARGET study. Eur J Nucl Med Mol Imaging (2022). https://doi.org/10.1007/s00259-022-05774-0.
  4. Reig M, Forner A, Rimola J, et al. BCLC strategy for prognosis prediction and treatment recommendation: The 2022 update. J Hepatol. 2021;S0168-8278(21)02223-6. doi:10.1016/j.jhep.2021.11.018.
  5. Salem R, Lewandowski R, Roberts C et al. J Vasc Interv Radiol. 2004; 15(4) 335-45
  6. Kulik LM, Atassi B, van Holsbeeck L et al. J Surg Oncol. 2006;94: 572-586
  7. Gaba RC, Lewandowski RJ, Kulik LM et al. Ann Surg Oncol. 2009 Jun;16(6):1587-96
  8. Riaz A, Gates VL, Atassi B et al. Int J Radiat Oncol Biol Phys. 2011 Jan 1;79(1):163-71
  9. Vouche M, Habib A, Ward TJ et al. Hepatology. 2014;60(1):192-201
  10. Lewandowski RJ, Gabr A, Abouchaleh N et al. Radiology. 2018;287(3) epub
  11. Garin et al, J Clin Oncol 38, 2020 (suppl 4; abstr 516)
  12. 3020.2: Yttrium-90 Glass Microspheres in the Treatment of Hepatocellular Carcinoma: The LEGACY Study,” CIRSE 2020 Virtual Summit, September 12-15, 2020; Salem R, Johnson GE, Kim E, Riaz A, Bishay V, Boucher E, Fowers K, Lewandowski R, Padia SA. Yttrium-90 Radioembolization for the Treatment of Solitary, Unresectable Hepatocellular Carcinoma:The LEGACY Study. Hepatology. 2021 Mar 19. doi: 10.1002/hep.31819.
  13. Kim E, Sher A, Abboud G, et al. Radiation segmentectomy for curative intent of unresectable very early to early stage hepatocellular carcinoma (RASER): a single-centre, single-arm study [published online ahead of print, 2022 May 23]. Lancet Gastroenterol Hepatol. 2022;S2468-1253(22)00091-7. doi:10.1016/S2468-1253(22)00091-7

*Refers to HCC or associated tumors.