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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121

Literatures (Medical) associated with Y-90 Resin Microspheres

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

Acute cytotoxic edema after radioembolization of the liver with Y-90 microspheres observed on DWI in post-therapy Y-90 PET/MRI

Article

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

27 Jul 2025·Future Oncology

Real-world outcomes of selective internal radiation therapy with ⁹⁰ Y resin microspheres in HCC/mCRC: RESIN registry Asia

Article

Author: Chotipanich, Chanisa ; Worakitsitisatorn, Akeanong ; Ng, David Chee-Eng ; Venkatanarashima, Nanda ; Liang, Po-Chin ; Lee, Rheun-Chuan ; Too, Chow Wei ; Tan, Zehao ; Zhuang, Kun Da ; Boonsingma, Nathapol ; Chao, Yee ; Gogna, Apoorva ; Loke, Kelvin Siu-Hoong ; Lo, Richard HG

AIM:

Asia-Pacific guidelines recommend selective internal radiation therapy (SIRT) as an alternative to transarterial chemoembolization for patients with intermediate or advanced hepatocellular carcinoma (HCC) and, in more limited circumstances, for metastatic colorectal cancer (mCRC). This multicenter, single-arm, prospective, observational registry evaluated safety and efficacy of SIRT with ⁹⁰Y resin microspheres for HCC or mCRC in Asia.

PATIENTS & METHODS:

Adults (n = 202) with HCC or mCRC eligible for, and scheduled to receive, SIRT with ⁹⁰Y resin microspheres at participating centers were recruited. Dosimetry methods used were body surface area or partition model at the physician's discretion. The primary endpoints were overall response rate (ORR), frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), and liver function baseline changes.

RESULTS:

ORR at 3 or 6 months was 56% (HCC) and 33% (mCRC). 491 TEAEs were reported in 125 patients and 71 SAEs were reported in 29 patients. Performance status was maintained or improved in most patients 6 months after SIRT.

CONCLUSION:

SIRT may offer clinicians a targeted, single-use approach for HCC or mCRC palliative care or for tumor down-sizing or down-staging in Asia. Controlled trials of SIRT using personalized dosimetry could further define a role for SIRT in these populations.

01 Jul 2025·ANNALS OF NUCLEAR MEDICINE

Comparative voxel-based dosimetry with pre-treatment Tc-99m SPECT/CT and post-treatment Y-90 PET/MRI for radioembolization with Y-90 microspheres

Article

Author: Kucuk, Nuriye Ozlem ; Bilgic, Mehmet Sadık ; Kuru Oz, Digdem ; Celebioglu, Emre Can ; Soydal, Cigdem ; Dursun, Ecenur ; Kir, Kemal Metin ; Inal, Gizem ; Demir, Burak ; Elhan, Atilla Halil

Abstract:

Purpose:

The aim of this study was to investigate the differences between voxel-based dosimetry and the mean absorbed doses calculated with pre-treatment Tc-99 m-MAA SPECT/CT and post-treatment Y-90 PET/MR images. We also sought to present a detailed comparison of dose-volume histograms (DVHs) calculated from pre- and post-treatment imaging.

Methods:

A total of 47 treatments and 41 patients were included in the analysis as six of the treatments were retreatments of the six patients. Multicompartment and voxel-based dosimetry were performed with pre-treatment Tc-99m-MAA SPECT/CT and Y-90 PET/MRI. Correlation coefficients between the two imaging methods for the mean absorbed dose of tumor, whole liver normal tissue, perfused normal tissue, T/N ratio and tumor D10, D50 and D90 values were calculated. Additionally, differences between these values were also evaluated with Bland–Altman plots.

Results:

Pre-treatment Tc-99m-MAA SPECT/CT accurately predicted the dose values for healthy liver parenchyma calculated with Y-90 PET/MRI but showed lower accuracy in predicting T/N ratio and tumor doses. There were significant variations in tumor-absorbed doses for both glass and resin microspheres. Additionally, D90 values were higher when calculated with SPECT/CT than with PET/MRI, whereas D10 values were higher in PET/MRI compared to SPECT/CT.

Conclusion:

The findings in our study suggest that Tc-99m-MAA SPECT/CT had higher accuracy in predicting the dose to the healthy liver parenchyma compared to the tumor, maintaining its importance in treatment planning.

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	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	South Korea	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	eakybeacqa(jclvfnxzbx) = hntwtplehi stexwoxyhd (zfgffcyeov, 9.24 - 39.6) View more	Positive	17 May 2025
TARGET Study99m Tc-MAA (EANM2022)	Not Applicable	Hepatocellular Carcinoma	209	Y-90 Glass Microspheres (Anatomic Workflow)	ogoxxgpqmv(bqcwwxerld): odds ratio = 1.22 (95% CI, 1.01 - 1.49), P-Value = 0.044 View more	-	22 Sep 2022
TARGET Study99m Tc-MAA (EANM2022)	Not Applicable	Hepatocellular Carcinoma	209	Y-90 Glass Microspheres99m Tc-MAA Microspheres (99m Tc-MAA SPECT Workflow)		-	22 Sep 2022
LEGACY (ASCO_GI2021)	Not Applicable	Hepatocellular Carcinoma Neoadjuvant	162	Yttrium-90 (Y90) glass microspheres (TheraSphere)	jrnbiqyupn(zatzqatsvf) = xeljamuihs isvufxvhnp (fkmftpspfb, 64.9% - 78.5%) View more	Positive	22 Jan 2021
LEGACY (ESMO2020)	Not Applicable	Advanced Hepatocellular Carcinoma Neoadjuvant	162	Y90 glass microspheres	xevdbopisp(yusbiguuon) = yopgsuehkb haquwokskm (mjkksfreoo, 64.9% - 78.5%) View more	Positive	17 Sep 2020
NEMESIS (ASCO2019)	Not Applicable	Advanced Hepatocellular Carcinoma	1,243	Selective Internal Radiation Therapy (SIRT)	vcvljlmobr(guoadqyjty) = 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) gxlsbqphfw (mnwotciibz ) View more	Positive	26 May 2019
NEMESIS (ASCO2019)	Not Applicable	Advanced Hepatocellular Carcinoma	1,243	Sorafenib		Positive	26 May 2019
SNMMI2019	Not Applicable	Hepatocellular Carcinoma	-	TARE+sorafenib	uitpollige(kgyxiwuwfy) = owiboesxyj vdlkqpnzwp (ieafbjxlte, 9.7 - 17.2)	-	21 May 2019
EASL2019	Not Applicable	Unresectable Hepatocellular Carcinoma	229	Y-90 resin microspheres	ikvyeaaukk(smxjrlhnjl) = gbnbxvheie paupsjxzka (azshoskvnn, 13.1 - â)	Positive	12 Apr 2019
ASTRO2018 Manual	Not Applicable	Unresectable Hepatocellular Carcinoma	-	Yttrium-90 Resin Microspheres(Y-90 SIRT)Yttrium-90 Resin Microspheres(Y-90 SIRT)	mxjgxpzxey(hjdiwfrvbp) = bjcugacnvc vkqadohxey (ttbrcwoccs, 12.4 - 26.1) View more	Positive	01 Nov 2018
ASTRO2018 Manual	Not Applicable	Unresectable Hepatocellular Carcinoma	-	Yttrium-90 Resin Microspheres(Y-90 SIRT) (white race)	mxjgxpzxey(hjdiwfrvbp) = aokzaddqjo vkqadohxey (ttbrcwoccs )	Positive	01 Nov 2018
SNMMI2018	Not Applicable	Neuroendocrine Tumors	-	Selective Internal Radiation Therapy with Y-90 resin microspheres	ufvkkfrblf(twtmapxmdi) = no grade 3 or 4 toxicities were observed ffxydjgzgb (avuuqefnup ) View more	-	23 May 2018
ASCO2017	Not Applicable	Pancreatic adenocarcinoma metastatic	24	Y-90 resin microspheres	gmikqdurce(xmzkuoyloa) = Most AEs were grade 1 or 2. Three patients had grade 3 AEs (abdominal distension or pain, fatigue, ascites, odynophagia, oral sores, biliary duct dilation), and 4 had grade 3 laboratory values (white blood cells, bilirubin, alkaline phosphatase, albumin). Two patients experienced grade 4 AEs, 1 with peripheral neuropathy and 1 with elevated ALT & AST suggesting post-radioembolization hepatitis. gvsmpqoclx (fmotwwjbjl )	-	30 May 2017