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

Target-

Mechanism

Ionising radiation emitters

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-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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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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604

Literatures (Medical) associated with Y-90 Resin Microspheres

01 Dec 2024·Materials Today Bio

99mTc/90Y radiolabeled biodegradable gel microspheres for lung shutting fraction assessment and radioembolization in hepatocellular carcinoma theranostics

Article

Author: Sun, Jing ; Hu, Di ; Yin, Lingling ; Zhong, Bin-Yan ; Zhu, Ran ; Wang, Guanglin ; Li, Zhihao ; Huang, Jintao ; Dong, Yi ; Zhang, Zhe

Transarterial radioembolization (TARE) is a well-established clinical therapy for the treatment of patients with intermediate to advanced hepatocellular carcinoma (HCC) or those who are ineligible for radical treatment. However, commercialized radioactive microspheres still have some issues, such as high density, complicated preparation, non-biodegradability. Furthermore, the use of different radioactive microspheres during TARE and lung shunt fraction assessment has led to inconsistencies in biodistribution in certain cases. This study employed biodegradable hyaluronic acid (HA) as the backbone and modified with bisphosphonate and methacrylic acid to prepare biodegradable gel microspheres (HAMS) using the water-in-oil emulsification and photo-crosslinking for labeling the diagnostic radionuclide of ^99mTc and therapeutic radionuclide of ⁹⁰Y. Both ^99mTc radiolabeled HAMS (^99mTc-HAMS) and radiolabeled ⁹⁰Y-HAMS (⁹⁰Y-HAMS) were highly efficient in radiolabeling and exhibited excellent radiostability in vitro and in vivo. ^99mTc-HAMS are highly effective in assessing the LSF, while ⁹⁰Y-HAMS, administered though TARE, are effective in inhibiting the growth of in situ HCC without any side effects. Both ^99mTc-HAMS and ⁹⁰Y-HAMS have promising clinical applications in HCC theranostics.

01 Nov 2024·Revista Española de Medicina Nuclear e Imagen Molecular (English Edition)

Radiosynoviorthesis with [90Y] Yttrium citrate in refractory synovitis of the knee: Experience of 2 reference hospitals

Article

Author: Jiménez-Heffernan, A ; Moreno Ballesteros, Ana ; Calvo Morón, M C ; Martínez Chinchilla, C ; Bolívar Roldán, I

INTRODUCTIONTo describe the therapeutic efficacy of radiosynoviorthesis with [⁹⁰Y]Yttrium citrate (⁹⁰Y), in patients with chronic knee synovitis refractory to systemic treatments and/or infiltrations, correlating the results with the different etiologies and degenerative changes that they showed, in order to optimize the indication of the technique.MATERIAL AND METHODSObservational retrospective study with 32 patients (22 men and 10 women) and 34 knees, with refractory chronic knee synovitis, who underwent radiosynoviorthesis between January 2013 and December 2022. Its efficacy was described and analyzed by the subjective improvement referred by the patients and its relationship with the existing etiologies and radiological degenerative changes, expressed by the Kellgren-Lawrence (K-L) scale.RESULTSA statistically significant subjective improvement was observed in 70.6% of the cases (p < 0.001). There were 92.3% of cases with absent, doubtful or mild degenerative changes (K-L 0-2) who improved, while only 50% with moderate or severe changes (K-L 3-4) improved, showing statistically significant differences (p = 0.03). Among patients with chronic inflammatory origin of synovitis (spondyloarthropathies and rheumatoid arthritis), 80% improved, while in those with osteoarthritis (degenerative) origin, only 25% improved with statistically significant differences (p = 0.006).CONCLUSIONSRadiosynoviorthesis with ⁹⁰Y is an effective treatment in patients with knee refractory chronic synovitis, especially in the presence of mil degenerative joint changes and chronic inflammatory origin. We must ensure the appropiate selection of patients according to these criteria.

01 Oct 2024·CHEST

A 78-Year-Old Man With Shortness of Breath After Radioembolization of the Liver

Article

Author: Alwakeel, Amr ; Jamjoom, Mohammed ; Sagar, Ala-Eddin S. ; Sagar, Ala-Eddin S

CASE PRESENTATIONA 78-year-old man with a history of GI stromal tumor (GIST) in the stomach with metastasis to the liver presented with progressive shortness of breath, dry cough, and subjective fever that started 1 week after radioembolization of liver metastatic lesions. His initial diagnosis of GIST was 10 years before, for which he underwent surgical resection; however, more recently he was noted to have hepatic lesions biopsy-proven to be metastatic GIST lesions. He stated that he did not have any respiratory symptoms before the radioembolization procedure and denied having a history of pulmonary disease. His medical history was otherwise notable for coronary artery disease post coronary artery bypass graft in 2002, heart failure with reduced ejection fraction, and atrioventricular block after pacemaker placement. After the diagnosis of liver metastasis, he began treatment with imatinib 6 months earlier and consequently received radioembolization with yttrium-90 (Y-90) microspheres.

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	SG	Hoffmann-La Roche, Inc.	26 Oct 2022
Locally Advanced Hepatocellular Carcinoma	Phase 2	CN	Hoffmann-La Roche, Inc.	26 Oct 2022
Locally Advanced Hepatocellular Carcinoma	Phase 2	TW	Hoffmann-La Roche, Inc.	26 Oct 2022
Locally Advanced Hepatocellular Carcinoma	Phase 2	KR	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


EANM2024	Not Applicable	Hepatocellular Carcinoma	27	Y-90 microspheres (Group 1 (T < 215 Gy))	(hsyfugftfu) = lscqbgzdqr hlamabiopl (cfepefjffh )	Positive	27 Sep 2024
				Y-90 microspheres (Group 2 (T ≥ 215 Gy))	(hsyfugftfu) = iytqjtgwkg hlamabiopl (cfepefjffh )
Dosisphere 01 (EANM2022)	Not Applicable	Liver Cancer	-	Y-90 microspheres (Patients treated in 2019)	zxnsindggm(bwsxjffhzl) = razlffuuns kfbdhbgrkr (lgvqqjpenw )	Positive	22 Sep 2022
				Y-90 microspheres (Patients treated in 2021)	zxnsindggm(bwsxjffhzl) = ypfyrzactc kfbdhbgrkr (lgvqqjpenw )
TARGET Study99m Tc-MAA (EANM2022)	Not Applicable	Hepatocellular Carcinoma	209	Y-90 Glass Microspheres (Anatomic Workflow)	(xgvdyfykbh): 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)
SNMMI2022	Not Applicable	Hepatocellular Carcinoma	47	Y-90 microspheres (Complete Response (CR))	(fieepxmrsy) = gqiorkqjcp czsssirbfh (bfnxdkppzt ) View more	Positive	08 Aug 2022
				Y-90 microspheres (Progression of Disease (PD))	snxepvizgh(ynnvwexzdd) = eazvujxgfk vsgzjzppae (dqbaiojhyx, 294.03)
EANM2021	Not Applicable	-	31	Y-90 microspheres (Local Deposition Method (LDM))	olwufgznnr(xappvphmmd) = aphsglspes wwqouzaqmr (viwddbrsqi, 24.79)	-	24 Sep 2021
				Y-90 microspheres (LDM with scaling (LDMwS))	olwufgznnr(xappvphmmd) = upnoyttllo wwqouzaqmr (viwddbrsqi, 21.54)
LEGACY (ASCO_GI2021)	Not Applicable	Hepatocellular Carcinoma Neoadjuvant	162	Yttrium-90 (Y90) glass microspheres (TheraSphere)	(rfpwmpzuvb) = wdvxjeppjc bdybctndfo (xcexmbhkpz, 64.9% - 78.5%) View more	Positive	22 Jan 2021
LEGACY (ESMO2020)	Not Applicable	Advanced Hepatocellular Carcinoma Neoadjuvant	162	Y90 glass microspheres	(ummuofwjfx) = kllxdmaiss ihhrgfomrb (frnieoxyad, 64.9% - 78.5%) View more	Positive	17 Sep 2020
EASL2019	Not Applicable	Unresectable Hepatocellular Carcinoma	229	Y-90 resin microspheres	dnkfyompzo(swpbkxqcqd) = euomoixrur irvexczlet (dnggoahwbj, 13.1 - â)	Positive	12 Apr 2019
EANM2017	Not Applicable	Bile Duct Neoplasms	18	Y-90 Microspheres (Glass Microspheres)	gwkcsdmhcy(ewmzbxexma) = wrxlqivhsu oyvaiaqrzr (ccsxhikhuf ) View more	-	11 Sep 2017
				Y-90 Microspheres (Resin Microspheres)	(sbbwomkopx) = vntikkwwve szxpcdzvtf (pblzrovets )
ASCO2017	Not Applicable	Pancreatic adenocarcinoma metastatic	24	Y-90 resin microspheres	vlbunoxsje(zzxbkrdxzy) = 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. ysccckwzsf (huyefkxmua )	-	30 May 2017