Delving into the Latest Updates on Y-90 Resin Microspheres with Synapse

Overview

Basic Info

Drug Type

Small molecule drug, Therapeutic radiopharmaceuticals

Synonyms

SIRT-Y90, Y90-SIRT

Target-

Action-

Mechanism-

Therapeutic Areas

NeoplasmsDigestive System Disorders

Active Indication

Locally Advanced Hepatocellular Carcinoma

Inactive Indication-

Originator Organization

National Cancer Centre of Singapore Pte Ltd.

Active Organization

Hoffmann-La Roche, Inc.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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To observe and evaluate the efficacy and safety of selective internal radiotherapy (SIRT) based on transarterial radioembolization with yttrium (90Y) microspheres combined with immune checkpoint inhibitors and anti-angiogenic-drug sequential hepatic arterial infusion chemotherapy (HAIC) for the treatment of initially unresectable hepatocellular carcinoma with transformation potential.

Start Date01 Mar 2025

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

NCT05377034

/ RecruitingPhase 2IIT

A Multinational, Double-blind, Placebo-Controlled, Parallel Randomized Arms, Phase II Trial to Compare Safety and Efficacy of Selective Internal Radiation Therapy (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab) Versus Selective Internal Radiation Therapy (SIRT-Y90) Followed by Placebo in Patients With Locally Advanced Hepatocellular Carcinoma (HCC)

This is a multi-national, phase II, parallel-arm, double-blind, placebo-controlled, two-arm study designed to assess the efficacy and safety of SIRT-Y90 followed by atezolizumab plus bevacizumab [study arm], versus SIRT-Y90 followed by placebo [control arm] in patients with locally advanced Hepatocellular Carcinoma (HCC).

Start Date26 Oct 2022

Sponsor / Collaborator

National Cancer Centre of Singapore Pte Ltd.

[+3]

100 Clinical Results associated with Y-90 Resin Microspheres

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100 Translational Medicine associated with Y-90 Resin Microspheres

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100 Patents (Medical) associated with Y-90 Resin Microspheres

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117

Literatures (Medical) associated with Y-90 Resin Microspheres

01 Apr 2025·European Journal of Nuclear Medicine and Molecular Imaging

Prediction of left lobe hypertrophy with voxel-based dosimetry using integrated Y-90 PET/MRI after radioembolization of liver tumors with Y-90 microspheres

Article

Author: Kuru Oz, Digdem ; Soydal, Cigdem ; Celebioglu, Emre Can ; Bilgic, Mehmet Sadık ; Kir, Kemal Metin ; Demir, Burak ; Kucuk, Nuriye Ozlem

PURPOSE:

The aim of this study was to investigate the relationship between voxel-based dosimetric variables derived from Y-90 PET/MRI and hypertrophy observed in the left lobe after radioembolization and to investigate if there is any difference in hypertrophy induced by glass versus resin microspheres.

METHODS:

Voxel-based dosimetry-derived variables and their relationship with the change of the standardized future liver remnant (ΔFLR) was investigated with linear regression models. To compare and evaluate the discriminatory power of the dosimetric variables, ROC analyses were utilized. ΔFLR and kinetic growth rate (KGR) induced with glass and resin microspheres were compared using the Mann-Whitney U test.

RESULTS:

In this retrospective study, data of the 40 patients treated with Y-90 microspheres were evaluated. Among the several dosimetric variables, the mean perfused volume normal tissue dose (pDnorm), perfused normal tissue V90 (pV90), and pV100 values for glass microspheres; and the mean whole liver normal tissue dose (Dnorm), pDnorm, whole liver normal tissue V30 (nV30), nV40, and pV40 for resin microspheres had the highest relationship with ΔFLR. In the ROC analysis for glass microspheres, the optimal cut-offs to predict ΔFLR > 5% were 60.55 Gy for Dnorm, 94.21 Gy for pDnorm, 28.07% for pV90, and 24.98% for pV100. For resin microspheres, corresponding values were 23.20 Gy for Dnorm, 37.40 Gy for pDnorm, 31.50% for nV30, 24.50% for nV40, and 43.60% for pV40. No significant difference was observed between glass and resin microsphere-induced median ΔFLR, KGR values and atrophy of the right lobe.

CONCLUSION:

Following Y-90 radioembolization therapy with glass and resin microspheres applied to the right lobe of the liver, ΔFLR is correlated with pDnorm and Dnorm, but is also significantly related to various nV and pV values. In addition, the hypertrophy and kinetic growth rates observed with glass and resin microspheres were largely similar.

01 Apr 2025·ANNALS OF NUCLEAR MEDICINE

Comparing laboratory toxicity of selective intra-arterial radionuclide therapy for primary and metastatic liver tumors: resin versus glass microspheres

Article

Author: Eldem, Gonca ; Bozkurt, M Fani ; Soydaş-Turan, Başak ; Ugur, Omer ; Peynircioglu, Bora ; Volkan-Salanci, Bilge

OBJECTIVE:

To compare the acute (within 30 days of treatment) laboratory toxicities of Yttrium-90 (Y-90) resin and glass microspheres.

METHODS:

Selective intra-arterial radionuclide therapies (SIRTs) with Y-90 resin and glass microspheres were retrospectively reviewed. Liver-hematological data were collected at baseline and at 1 week and 1 month follow-up. The percentage change of laboratory data and the albumin-bilirubin (ALBI) score were calculated.

RESULTS:

A total of 219 SIRTs (n: 110 resin, n: 109 glass) from 177 patients were included. There was no difference in age, liver pathologies, extrahepatic disease, baseline liver function tests, and total blood counts between the two microsphere groups. Administered activity was higher in treatments with Y-90 glass microspheres (p < 0.001). An increase in serum liver enzymes was observed after treatment with both microspheres. The difference between the treatment groups was the higher percentage increase of AST and ALT at the first week following Y-90 glass treatment (p < 0.001). However, this situation was not observed after 1 month. No difference in the percentage change of other laboratory parameters was found between two groups. The number of patients with an increase [resin n: 24 (24.7%) vs glass n: 26 (27.1%), p: 0.711) and decrease [resin n: 13 (13.4%) vs glass n: 8 (8.3%), p: 0.258] in the ALBI grade after SIRT was similar among groups.

CONCLUSIONS:

An increase in liver enzymes was observed in the early period after SIRT with both microspheres. No significant difference in liver and hematological data was detected during early follow-up between the two groups, except that the percentage increase of AST and ALT were higher at the first week in the Y-90 glass group, possibly due to higher administered activity.

01 Jan 2025·IN VIVO

Lesion Volume Divided by ADC Measures Is an Independent Prognostic Marker in Colorectal Liver Metastasis Treated by Y90-radioembolization

Article

Author: Christ, Sebastian M ; Pech, Maciej ; Thormann, Maximilian ; Damm, Robert ; March, Christine ; Heitmann, Franziska

BACKGROUND/AIM:

To assess the ability of apparent diffusion coefficient (ADC) at baseline in predicting overall survival in patients who undergo Y90-radioembolization (Y90-RE) for liver-dominant metastatic colorectal cancer (mCRC) in the salvage situation.

PATIENTS AND METHODS:

A retrospective review of 411 lesions in 63 patients with refractory mCRC treated with Y90-RE was conducted. Manual region of interest (ROI) measurements were applied using a whole lesion and volume method. Minimum and mean ADC values were measured, and averages were calculated per patient. Ratios combining tumor volume and ADC were correlated with OS, and a receiver-operating characteristic (ROC) analysis defined a cut-off value. Cox regression analysis was performed, and the log-rank test confirmed prognostic cut-off levels for survival.

RESULTS:

The median survival was 6.4 months. Multivariate Cox regression identified tumor volume divided by minimum ADC (ADC_{tumor volume, min}) as an independent predictor of OS (HR=1.814, 95%CI=1.188-2.770, p=0.006). Neither ADCmin nor ADCmean were significantly associated with survival. Optimal prediction was identified with a ADC_{tumor volume, min} cut-off of 0.3673 arbitrary units (AU) yielding 76.0% sensitivity and 70.3% specificity. Patients with ADC_{tumor volume min} <0.3673 had a median OS of 10.4 months, compared to 4.7 months for those above the cut-off (p<0.001).

CONCLUSION:

Tumor volume divided by minimum ADC at baseline (ADC_{tumor volume, min}) was identified as an independent predictor of OS in mCRC scheduled for Y90-radioembolization in the salvage situation and may improve future patient selection.

2

News (Medical) associated with Y-90 Resin Microspheres

16 Sep 2024

·www.prnewswire.com

Sirtex Medical Announces Certification of SIR-Spheres® Y-90 Resin Microspheres According to Medical Device Regulation (EU) 2017/745 and European Launch of the Innovative SIROS™ Delivery System

Sirtex brings an innovative liver cancer treatment delivery system to Europe, enhancing options for physicians and their patients. WOBURN, Mass., Sept. 16, 2024 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of interventional treatment solutions, today announced that it has received certification according to Medical Device Regulation (EU) 2017/745 for SIR-Spheres® Y-90 resin microspheres and its delivery systems, paving the way for the European launch of the SIROS™ Delivery System. The EU MDR places greater emphasis on patient safety measures, risk management, post-market surveillance, and comprehensive data collection for medical devices seeking European market access. "Patient health and safety are always at the forefront of our work. That is why we are particularly proud to receive EU MDR certification for SIR-Spheres® Y-90 resin microspheres and its delivery systems, including SIROS™. This achievement underscores our commitment to delivering innovative products responsibly and ethically," said Matt Schmidt, CEO of Sirtex Medical Inc. "With the expansion of SIROS™ outside of the U.S., interventional radiologists in Europe now have an additional option to support patients battling metastatic colorectal cancer (mCRC) and unresectable hepatocellular carcinoma (HCC). This milestone reflects the outstanding efforts of our team, the rapid growth of our business, and the groundbreaking interventional oncology solutions we have developed." The SIROS™ Delivery System offers an intuitive, visual, and adaptable solution for physicians to administer SIR-Spheres® to liver cancer patients. Its easy-to-use design along with controlled administration provides physicians confidence in the Y-90 delivery. "As an interventional radiologist, I am excited about the future use of the SIROS™ Delivery System," shared Professor Thomas Helmberger, Head of Department of Radiology, Neuroradiology, and Minimal-Invasive Therapy at München Klinik Bogenhausen in Munich, Germany. "This device has an intuitive design and a precise control that will facilitate the administration of SIR-Spheres® Y-90 resin microspheres, and I am looking forward to incorporating it into my practice." About SIR-Spheres® in Europe SIR-Spheres® are medical devices used in selective internal radiation therapy (SIRT) and are indicated for the treatment of unresectable hepatocellular carcinoma (HCC) and unresectable metastatic liver tumors from primary colorectal cancer (mCRC) in patients refractory to or intolerant of chemotherapy. For a complete listing of indications, contraindications, side effects, warnings, and precautions, please consult the Instructions for Use at . About Sirtex Sirtex is a global healthcare company with offices in the U.S., Australia, Europe, and Asia, dedicated to improving patients' quality of life and longevity through innovative, minimally invasive cancer and embolization therapies. Sirtex's current leading product, SIR-Spheres® Y-90 resin microspheres, offers targeted radiation therapy for liver cancer. For more information, visit . SOURCE Sirtex Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Radiation Therapy

15 Sep 2022

·www.prnewswire.com

Sirtex Medical secures positive approval of SIR-Spheres® Y-90 resin microspheres for HCC treatment in Brazil

The Brazilian National Agency of Supplementary Health recommends SIR-Spheres for the treatment of intermediate- and advanced-stage hepatocellular carcinoma WOBURN, Mass., Sept. 15, 2022 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of targeted liver cancer therapies, announced that the Brazilian National Agency of Supplementary Health (ANS) approved SIR-Spheres® Y-90 resin microspheres for the treatment of intermediate and advanced stage hepatocellular carcinoma (HCC) in Brazil. In an update to its List of Health Procedures and Events, ANS recommends SIR-Spheres for use in selective internal radiation therapy (SIRT), a minimally invasive treatment that delivers high doses of radiation directly to tumors while sparing surrounding healthy liver tissue. Sirtex received product approval from the Brazilian Health Regulatory Agency (ANVISA) for SIR-Spheres in 2014. "This milestone represents the close collaboration we have fostered with Brazilian colleagues, interventional radiologists and respected regulatory entities like ANS over the last six years," said Kevin R. Smith, Chief Executive Officer of Sirtex. "We celebrate the recognition of SIR-Spheres to advance care for HCC patients, and we also reaffirm our commitment to global growth and partnership for more effective cancer treatment worldwide." The proposals for incorporation into the ANS List of Health Procedures and Events underwent broad social participation and careful technical analysis by the ANS, using the methodology of health technology assessment, similar to England, Canada, Australia and Germany. In Brazil, liver cancer has the 11th-highest cancer incidence, representing 2.1% of new cases and 4.7% of total cancer-related deaths, which highlights the burden and severity of this disease. "The ANS recommendation of SIR-Spheres solidifies it as a valuable treatment option, especially since 76% of HCC patients in Brazil are diagnosed at an advanced stage when treatments of curative intent are no longer an option1," said Dr. Joaquim Maurício da Motta Leal Filho, President of the Brazilian Society of Interventional Radiology and Endovascular Surgery (SOBRICE). "As we continuously strive to improve outcomes for patients, we are proud of this achievement and feel gratitude to the many people who contributed to this decision." In addition to Brazil, SIR-Spheres are approved for use in Argentina, Australia, Switzerland, Turkey, and several countries in Asia for the treatment of unresectable liver tumors. In the U.S., SIR-Spheres Y-90 resin microspheres have a Pre-Market Approval (PMA) from the FDA and are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (floxuridine). 1 Fernandes GDS et al. Epidemiological and Clinical Patterns of Newly Diagnosed Hepatocellular Carcinoma in Brazil: the Need for Liver Disease Screening Programs Based on Real-World Data. J Gastrointest Cancer. 2021 Sep;52(3):952-958. doi: 10.1007/s12029-020-00508-7. Erratum in: J Gastrointest Cancer. 2020 Oct 26;: PMID: 32918274; PMCID: PMC8376733. About Sirtex Sirtex is a global healthcare business with offices in the U.S., Australia, Europe and Asia, working to improve outcomes in people with cancer. Sirtex's current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. For more information, visit . SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd. APM-GL-001-09-22 SOURCE Sirtex

Radiation Therapy

100 Deals associated with Y-90 Resin Microspheres

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Hepatocellular Carcinoma	Phase 2	United States	Hoffmann-La Roche, Inc.	26 Oct 2022
Locally Advanced Hepatocellular Carcinoma	Phase 2	China	Hoffmann-La Roche, Inc.	26 Oct 2022
Locally Advanced Hepatocellular Carcinoma	Phase 2	Singapore	Hoffmann-La Roche, Inc.	26 Oct 2022
Locally Advanced Hepatocellular Carcinoma	Phase 2	Taiwan Province	Hoffmann-La Roche, Inc.	26 Oct 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	Hepatocellular Carcinoma	142	Y90-SIRT	scwkjavzsr(jgewupgypb) = auxktldnka wngguoepfb (bazglwimao, 9.24 - 39.6) View more	Positive	17 May 2025
EANM2024	Not Applicable	Hepatocellular Carcinoma	27	Y-90 microspheres (Group 1 (T < 215 Gy))	hqbsqexbdj(rpvhcrgovq) = svxkpwfkqu jdhchsutki (evwlazbyha )	Positive	27 Sep 2024
				Y-90 microspheres (Group 2 (T ≥ 215 Gy))	hqbsqexbdj(rpvhcrgovq) = zmlgauktgw jdhchsutki (evwlazbyha )
TARGET Study99m Tc-MAA (EANM2022)	Not Applicable	Hepatocellular Carcinoma	209	Y-90 Glass Microspheres (Anatomic Workflow)	jdifmsdwqk(utprgqpaky): odds ratio = 1.22 (95% CI, 1.01 - 1.49), P-Value = 0.044 View more	-	22 Sep 2022
				Y-90 Glass Microspheres99m Tc-MAA Microspheres (99m Tc-MAA SPECT Workflow)
Dosisphere 01 (EANM2022)	Not Applicable	Liver Cancer	-	Y-90 microspheres (Patients treated in 2019)	nmqgiozhnz(zorqeznyxk) = bhitcokhzw phdilgavgx (pzkjphfptx )	Positive	22 Sep 2022
				Y-90 microspheres (Patients treated in 2021)	nmqgiozhnz(zorqeznyxk) = hyvvywltza phdilgavgx (pzkjphfptx )
SNMMI2022	Not Applicable	Hepatocellular Carcinoma	47	Y-90 microspheres (Complete Response (CR))	lrlvphupri(gxqlonxjec) = oghndhbidb xwbdymxmqa (bvkhcmpbnf ) View more	Positive	08 Aug 2022
				Y-90 microspheres (Progression of Disease (PD))	aaxyzdtvek(hxdygcndzx) = aqbjwzwxcm hjoyyltajg (itcotivwar, 294.03)
EANM2021	Not Applicable	-	31	Y-90 microspheres (Local Deposition Method (LDM))	nwiqspxtrl(kvjqygtykb) = dtfjleaink vqsioylnzx (zmbiirezlh, 24.79)	-	24 Sep 2021
				Y-90 microspheres (LDM with scaling (LDMwS))	nwiqspxtrl(kvjqygtykb) = kyfojxlecf vqsioylnzx (zmbiirezlh, 21.54)
LEGACY (ASCO_GI2021)	Not Applicable	Hepatocellular Carcinoma Neoadjuvant	162	Yttrium-90 (Y90) glass microspheres (TheraSphere)	amwjljbwbc(lmkwuvtroa) = snfitwsaue jlrggzrwpf (wvqdabvalg, 64.9% - 78.5%) View more	Positive	22 Jan 2021
LEGACY (ESMO2020)	Not Applicable	Advanced Hepatocellular Carcinoma Neoadjuvant	162	Y90 glass microspheres	ajjixilnur(xculfvhqsf) = igasfmzkzi irmzxeyjrq (rtuwtihgfj, 64.9% - 78.5%) View more	Positive	17 Sep 2020
NEMESIS (ASCO2019)	Not Applicable	Advanced Hepatocellular Carcinoma	1,243	Selective Internal Radiation Therapy (SIRT)	bnesxwudjw(qtvsfmqlfu) = Treatment-related AEs grades ≥3 were reported in 109/356 (30.6%) patients who received SIRT and 197/378 (52.1%) patients in the sorafenib arm (SIRveNIB and SARAH only, p = 0.0002) viijwtiujh (nsmcojcrvu ) View more	Positive	26 May 2019
				Sorafenib
SNMMI2019	Not Applicable	Hepatocellular Carcinoma	-	TARE+sorafenib	nrnvchyzfz(jzrozdhnws) = gvxdbjkilt oypzsvifes (sjuexoatts, 9.7 - 17.2)	-	21 May 2019