Drugs / Yttrium-90
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05195710 | Nov 2022 → Mar 2028 expected | metastatic neoplasm | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06725121 | Dec 2024 → Jun 2031 expected | hepatocellular carcinoma, invasive carcinoma | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06555133 | Apr 2025 → Sep 2026 overdue | colorectal carcinoma | Brown University | Recruiting | No outcome recorded |
| Phase 2 | NCT02167711 | Sep 2014 → Jan 2023 | intrahepatic cholangiocarcinoma | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04518748 | Sep 2020 → Dec 2026 expected | liver cancer | University of Michigan Rogel Cancer Center | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT01381211 Comparator | Sep 2011 → Mar 2018 | hepatocellular carcinoma | University Hospital, Ghent | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-04-13 | Sirtex Medical | Results Sirtex Medical’s DOORwaY 90 Study Demonstrates 100% Local Tumor Control with SIR-Spheres® , Setting a New Benchmark in Y-90 for HCC sirtex.com ↗
The DOORwaY 90 study met its prespecified co-primary endpoints, demonstrating a 90% complete response (CR) rate and a best overall response rate (ORR) of 99%, as assessed by blinded independent central review. |
| 2025-09-08 | Sirtex Medical | Regulatory Sirtex Receives Expanded CE Mark Approval for SIR-Spheres® Y-90 Resin Microspheres sirtex.com ↗
today announced that it has received an expanded CE Mark approval for SIR-Spheres ® Y-90 resin microspheres for the treatment of patients with liver cancer. |
| 2025-07-07 | Sirtex Medical | Regulatory Sirtex Medical’s SIR-Spheres ® Y-90 Resin Microspheres Receive FDA Approval for the Treatment of Unresectable Hepatocellular Carcinoma sirtex.com ↗
Sirtex Medical (“Sirtex”), a leading manufacturer of interventional oncology solutions, today announced that the U.S. Food and Drug Administration (FDA) approved SIR-Spheres ® Y-90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the United States. |
| 2024-09-16 | Sirtex Medical | Regulatory 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.com ↗
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™. |
| 2022-02-09 | Sirtex Medical | Regulatory Sirtex Medical and Grand Pharmaceutical Group Limited receive NDA approval of SIR-Spheres ® Y-90 resin microspheres in China from the National Medical Products Administration sirtex.com ↗
The NDA approval of SIR-Spheres for the Chinese market is the first therapeutic radiopharmaceutical approved by the NMPA in 2022 and is the only radioactive microsphere product approved by the NMPA based on clinical trial data obtained outside of China. |
| 2021-09-20 | Boston Scientific Corporation | Results Late-Breaking Data Demonstrate Improved Progression-Free Survival in Patients with Metastatic Colorectal Cancer After Treatment with Boston Scientific TheraSphere™ Y-90 Glass Microspheres bostonscientific.com ↗
The clinical findings were presented today as late-breaking data at the European Society for Medical Oncology (ESMO) Congress 2021 and will be published in the Journal of Clinical Oncology . |
| 2021-03-25 | Boston Scientific Corporation | Results Late-Breaking Clinical Trial Data for TheraSphere™ Y-90 Glass Microspheres Demonstrates Improved Survival in Primary Liver Cancer bostonscientific.com ↗
Data confirmed treatment was safe and well tolerated, with only 4.8% of patients experiencing adverse events, defined in the primary endpoint as ≥ Grade 3 hyperbilirubinemia. |
| 2021-03-18 | Boston Scientific Corporation | Regulatory Boston Scientific Receives FDA Approval for TheraSphere™ Y-90 Glass Microspheres bostonscientific.com ↗
Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval of the TheraSphere™ Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma (HCC). |
| 2021-02-26 | Sirtex Medical | Regulatory Sirtex Medical receives positive recommendation from National Institute for Health and Care Excellence (NICE) for selective internal radiation therapy (SIRT) using SIR-Spheres® sirtex.com ↗
NICE recommends the use of SIRT using SIR-Spheres in England and Wales as a fully funded and reimbursed option for adult patients with HCC, on the conditions that it is used for people with Child-Pugh grade A liver impairment when conventional transarterial therapies are inappropriate, and that the company provides SIR-Spheres according to the commercial arrangement. |
| 2018-03-29 | Delcath Systems Inc. | Results Summary of Recent Published Research on Delcath’s PHP Therapy Presented at Society of Surgical Oncology Annual Symposia delcath.com ↗
Karydis showed an overall response rate with PHP of 47%, a >84% disease control rate and hPFS of 9.1 months. |
| 2017-07-03 | Sirtex Medical | Results New Analysis Reveals First-Line Treatment Data on SIR-Spheres ® Y-90 Resin Microspheres for Patients with Liver Metastases from Right-Sided Primary Colon Cancer sirtex.com ↗
This translates into a 36% reduction in the risk of death at any given time compared to patients who received chemotherapy alone. |
| 2017-06-05 | Sirtex Medical | Results SIR-Spheres ® Y-90 Resin Microspheres Showed no Significant Difference in Overall Survival (OS) Compared to Sorafenib in Advanced HCC with Significantly Fewer Severe Adverse Events, New Asia-Pacific Study Finds PDF Languages sirtex.com ↗
They also experienced almost a two-fold decrease in severe adverse events (grade ≥3; 27.7% vs . 50.6%; p<0.0001) compared with those treated with sorafenib. |
| 2017-06-05 | Sirtex Medical | Results FOXFIRE Combined Analysis Results in First-Line Treatment of Metastatic Colorectal Cancer Presented at ASCO sirtex.com ↗
Our analysis did not meet its primary endpoint of an overall survival (OS) benefit for patients treated with SIRT plus first-line chemotherapy compared to patients treated with chemotherapy alone. |
| 2017-05-24 | Sirtex Medical | Results Metastatic colorectal cancer patients treated first-line with SIR-Spheres ® Y-90 resin microspheres more likely to become candidates for potentially curative liver surgery, REsect study shows PDF Languages sirtex.com ↗
Adding selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres to first-line FOLFOX-based chemotherapy was associated with a statistically significant gain in potentially curative liver resectability, an independent, international panel of expert liver surgeons has reported. |
| 2017-05-18 | Sirtex Medical | Results American Society of Clinical Oncology (ASCO) publishes abstract of SIRveNIB, an Investigator-led Asia Pacific Primary Liver Cancer Study to be presented at ASCO Annual Meeting in Chicago, 4 June 2017 sirtex.com ↗
There were no statistically significant differences in the primary endpoint of overall survival (OS) between the two treatments. |
| 2016-07-01 | Sirtex Medical | Results Patients with Colorectal Cancer Liver Metastases Had Significantly Greater Depth of Tumour Response to SIR-Spheres ® Y-90 resin microspheres, New SIRFLOX Analysis Shows PDF Languages sirtex.com ↗
Patients also had a statistically significant, two-month longer time to DpR or maximal tumour shrinkage (median 266 vs . 206 days; p<0.001), compared to those who received chemotherapy alone. |
All press releases naming this drug 26 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Yttrium-90 | “Glass Yttrium-90 microspheres (TheraSphere®; MDS Nordion Inc.) will be used” NCT01381211 ↗ |
| Known as | Y-90 | “Y-90 radioembolization one or both hemilivers based on distribution of disease” NCT06555133 ↗ |
| Modality | Other / unclassified | “Radioactive isotope Y-90” NCT04518748 ↗ |
| Route | Other | “Yttrium-90 radioembolization ((90)Y-RE) involves the transarterial administration of minimally embolic microspheres loaded with Yttrium-90” PMID 22913492 ↗ Aug 2012 |