ibritumomab tiuxetan
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Zevalin | — | 2024-01-04 | europa.eu ↗ |
| Label expansions (4) | US (FDA) | ZEVALIN | — | 2004-10-22 – 2011-11-18 | fda.gov ↗ |
| Approved | EU (EMA) | Zevalin | — | 2004-01-16 | europa.eu ↗ |
| Approved | US (FDA) | ZEVALIN | — | 2002-02-19 | fda.gov ↗ |
Trials 47
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00186589 | May 2004 → Jul 2007 | non-Hodgkin lymphoma | Stanford University | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT00807196 | Sep 2008 → Dec 2011 | non-Hodgkin lymphoma | Maisonneuve-Rosemont Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT00372905 | Jul 2007 → Jun 2010 | lymphoma | Northwestern University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00302757 | Mar 2006 → Jul 2011 | non-Hodgkin lymphoma | University Hospital Tuebingen | Completed | No outcome recorded |
| Phase 1/2 | NCT00089284 | Oct 2003 → Jan 2007 | non-Hodgkin lymphoma | Northwestern University | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT00048737 | Oct 2002 → Dec 2011 | leukemia, lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 229 trials | ||||||
| Phase 2 | NCT01811368 | Mar 2013 → Apr 2023 | non-Hodgkin lymphoma | Joseph Tuscano | Unknown | No outcome recorded |
| Phase 2 | NCT01497275 | Feb 2012 → May 2014 | mantle cell lymphoma | Duke University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00662948 | Dec 2008 → Oct 2014 | lymphoma | PETHEMA Foundation | Completed | No outcome recorded |
| Phase 2 | NCT00722930 | Apr 2008 → Apr 2011 | follicular lymphoma | Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas | Unknown | No outcome recorded |
| Phase 2 | NCT00607854 | Feb 2008 → Feb 2011 | diffuse large B-cell lymphoma, mantle cell lymphoma | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 2 | NCT00644371 | Nov 2007 → Feb 2011 | non-Hodgkin lymphoma | Spanish Lymphoma Cooperative Group | Completed | No outcome recorded |
| Phase 2 | NCT00772655 | Oct 2007 → Jun 2010 | follicular lymphoma | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 2 | NCT00689169 | Aug 2007 → Jan 2011 | diffuse large B-cell lymphoma | Lymphoma Study Association | Completed | No outcome recorded |
| Phase 2 | NCT01157988 | Jan 2007 → Jan 2009 | diffuse large B-cell lymphoma | Chonnam National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00440583 | Sep 2006 → Sep 2011 | diffuse large B-cell lymphoma | Mahidol University | Completed | No outcome recorded |
| Phase 2 | NCT00493467 | Jun 2006 → Apr 2015 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00386321 | Apr 2006 → Jul 2007 | diffuse large B-cell lymphoma | Chulalongkorn University | Terminated | No outcome recorded |
| Phase 2 | NCT00493454 | Apr 2006 → Mar 2011 | lymphoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00521560 | Mar 2006 → Aug 2009 | aggressive B-cell non-Hodgkin lymphoma | Institute of Application-oriented Research and Clinical Trials GmbH | Completed | No outcome recorded |
| Phase 2 | NCT00453102 | Feb 2006 → Feb 2015 | marginal zone lymphoma | University of Miami | Completed | No outcome recorded |
| Phase 2 | NCT00505232 | Jan 2006 → Mar 2010 | mantle cell lymphoma | CABYC | Completed | No outcome recorded |
| Phase 2 | NCT00354822 | Aug 2005 → Aug 2009 | non-Hodgkin lymphoma | A.O. Ospedale Papa Giovanni XXIII | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00138086 | Mar 2005 → Mar 2009 | indolent B-cell non-Hodgkin lymphoma | Lymphoma Study Association | Completed | No outcome recorded |
| Phase 2 | NCT00119730 | Feb 2005 → Dec 2006 | mantle cell lymphoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00582166 | Jan 2005 → Mar 2013 | non-Hodgkin lymphoma | University of Wisconsin, Madison | Terminated | No outcome recorded |
| Phase 2 | NCT00220285 | Aug 2004 → Oct 2005 | B-cell non-Hodgkin lymphoma | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00290511 | Jun 2004 → Feb 2021 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00070447 | Nov 2003 → Jun 2006 | lymphoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00177554 | Nov 2003 → May 2007 | non-Hodgkin lymphoma | University of Pittsburgh | Completed | No outcome recorded |
| Phase 2 | NCT00193440 | Apr 2002 → Apr 2004 | non-Hodgkin lymphoma | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00038623 | Apr 2002 → Dec 2007 | mantle cell lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00005592 | Nov 1999 → Mar 2002 | lymphoma | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT00850512 | — | diffuse large B-cell lymphoma | University of Bologna | Completed | No outcome recorded |
| Phase 2 | NCT00859001 | — | follicular lymphoma | University of Bologna | Completed | No outcome recorded |
| Phase 310 trials · 1 missed | ||||||
| Phase 3 | NCT01662102 | Dec 2012 → Mar 2013 | follicular lymphoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02063685 | Jul 2012 → Dec 2021 | follicular lymphoma | Fondazione Italiana Linfomi - ETS | Completed | Missed primary |
| Phase 3 | NCT01510184 | Apr 2012 → Oct 2014 | diffuse large B-cell lymphoma, follicular lymphoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 3 | NCT00491491 | Jun 2007 → Feb 2015 | non-Hodgkin lymphoma | Sheba Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00463463 | Apr 2007 → ? | non-Hodgkin lymphoma | Soroka University Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT00384111 | Oct 2006 → Nov 2008 | follicular lymphoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 3 | NCT00322218 | May 2006 → Dec 2008 | diffuse large B-cell lymphoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00319332 | Sep 2005 → Feb 2021 | follicular lymphoma | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00057343 | Mar 2003 → ? | non-Hodgkin lymphoma | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT00185393 | Aug 2001 → Feb 2007 | non-Hodgkin lymphoma | Bayer | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00168727 | Jun 2003 → Oct 2005 | non-Hodgkin lymphoma | Biogen | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00387023 | Feb 2004 → Jul 2012 | non-Hodgkin lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT00392691 Background | Oct 2006 → Dec 2012 | lymphoma | Swiss Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT04189588 Comparator | Mar → Nov 2020 | — | TerSera Therapeutics LLC | Completed | No outcome recorded |
| Phase 2 | NCT00591630 Comparator | Nov 2007 → Mar 2020 | diffuse large B-cell lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-02-19 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Announces China National Medical Products Administration (NMPA) Approval Of CTA To Conduct Confirmatory Clinical Trial For ZEVALIN® issuerdirect.com ↗
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. based pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, U.S., and throughout the world, today announced that the National Medical Products Administration (NMPA) has approved the Company's Clinical Trial Application (CTA) to allow for a confirmatory clinical trial to evaluate the efficacy and safety of ibritumomab tiuxetan injection (ZEVALIN®). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-02-19 | CASI pharmaceuticals, Inc. | CASI Pharmaceuticals Announces China National Medical Products Administration (NMPA) Approval Of CTA To Conduct Confirmatory Clinical Trial For ZEVALIN® issuerdirect.com ↗ |
| 2015-07-20 | CASI pharmaceuticals, Inc. | CASI Pharmaceuticals Announces Availabilty Of Anti-Cancer Drug ZEVALIN® In Hong Kong For Non-Hodgkin's Lymphoma issuerdirect.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 54 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ibritumomab -tiuxetan | “A Phase 3 Open Label Multicenter, Randomized Study to Compare the Efficacy and Safety of the Zevalin (Ibritumomab Tiuxetan) Therapeutic Regimen Following Cyclophosphamide,...” NCT00384111 ↗38“Yttrium-90 (90Y) ibritumomab tiuxetan 0.4 mCi/kg is delivered to patient achieving at least a partial remission (PR) after chemotherapy as a single dose for patients with...” NCT00354822 ↗ “short-course chemoimmunotherapy with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (CHOP-R) followed by 90-Y ibritumomab tiuxetan (RIT) with extended...” PMID 18981007 ↗ Nov 2008 “We therefore subsequently performed a trial in which (90)Y-ibritumomab tiuxetan (0.4 mCi/kg) was added to the fludarabine, cyclophosphamide conditioning regimen ((90)YFC).” PMID 22586182 ↗ May 2012 “Ibritumomab tiuxetan ("Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to the chelating agent tiuxetan.” NCT00850512 ↗ “patients receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 Zevalin®) IV over 10 minutes on day 8.” NCT00070447 ↗ “Ibritumomab tiuxetan (another similar monoclonal antibody, which delivers radiation to the lymphoma cells to strengthen the attack).” NCT00290511 ↗ “Ibritumomab tiuxetan is an antibody targeted against CD20, which carries a radioactive material called 90-Yttrium.” NCT00038623 ↗ “After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1.” NCT00089284 ↗ “radioimmunotherapy (RIT) using yttrium-90-ibritumomab tiuxetan at two dose levels (22 and 30 MBq/kg)” PMID 22504934 ↗ Apr 2012 “one \[90Y\]-ibritumomab tiuxetan infusion in connection with the second rituximab infusion” NCT00322218 ↗ |
| Known as | (90)Y-ibritumomab tiuxetan | “A single course of 90Y-Ibritumomab Tiuxetan (according to the standard procedure that includes Rituximab 250 mg/m2 plus 111In-Ibritumomab Tiuxetan for dosimetry on day one...” NCT00772655 ↗5“The clinical efficacy and safety of yttrium-90 ((90)Y)-ibritumomab tiuxetan consolidation treatment following rituximab” PMID 22035417 ↗ Dec 2011 “Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg” NCT00662948 ↗ “90Y-ibritumomab tiuxetan Consolidation After 6th R-CHOP Chemotherapy” NCT01157988 ↗ “a single course of IDEC-Y2B8 (90Y-ibritumomab tiuxetan, Zevalin)” NCT00186589 ↗ “Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)” NCT00185393 ↗ |
| Known as | 90Y Zevalin | “On day 8, within 4 hours following completion of the rituximab dose, 90Y Zevalin at a dose of 0.4 mCi/kg actual body weight” NCT01157988 ↗ |
| Known as | 90Y-IT | “Radioimmunotherapy with 90-yttrium-ibritumomab tiuxetan (90Y-IT) as first-line treatment in patients with follicular lymphoma (FL) demonstrated promising results with a...” PMID 35150296 ↗ Feb 2022 |
| Known as | 90Yttrium-Ibritumomab Tiuxetan | “Radioimmunotherapy with 90-yttrium-ibritumomab tiuxetan (90Y-IT) as first-line treatment in patients with follicular lymphoma (FL) demonstrated promising results with a...” PMID 35150296 ↗ Feb 20221“This is a European multicenter study of 90Yttrium-Ibritumomab Tiuxetan (90Y-Ibritumomab Tiuxetan) (Zevalin®) as a front line therapy for patients with follicular lymphoma grade...” NCT00772655 ↗ |
| Known as | BAY86-5128 | “Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)” NCT00185393 ↗1“Zevalin (SH L 749 , BAY86-5128)” NCT00220285 ↗ |
| Known as | IDEC-Y2B8 | “patients receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 Zevalin®) IV over 10 minutes on day 8.” NCT00070447 ↗2“IDEC-Y2B8 is a mouse monoclonal antibody with small particles of radioactivity that join to the CD20 antigens on lymphoma cells.” NCT00005592 ↗ “a single course of IDEC-Y2B8 (90Y-ibritumomab tiuxetan, Zevalin)” NCT00186589 ↗ |
| Known as | SH L 749 | “Zevalin (SH L 749 , BAY86-5128)” NCT00220285 ↗ |
| Known as | Y-90 ibritumomab-tiuxetan | “We designed a phase II clinical trial including Y-90 ibritumomab-tiuxetan as part of a reduced-intensity conditioning (RIC) allogeneic stem cell transplantation (AlloSCT) in...” PMID 27771496 ↗ Oct 20161“Y90-Ibritumomab -Tiuxetan (Zevalin)” NCT00505232 ↗ |
| Known as | Yt90-ibritumomab tiuxetan | “Ibritumomab is covalently linked to the tiuxetan chelate and radiolabeled with Yt90, producing Yt90-ibritumomab tiuxetan (Yt90-Zevalin).” NCT00440583 ↗ |
| Known as | Yt90-Zevalin | “Ibritumomab is covalently linked to the tiuxetan chelate and radiolabeled with Yt90, producing Yt90-ibritumomab tiuxetan (Yt90-Zevalin).” NCT00440583 ↗ |
| Known as | yttrium Y 90 ibritumomab tiuxetan | “patients receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 Zevalin®) IV over 10 minutes on day 8.” NCT00070447 ↗ |
| Known as | yttrium Y 90 Zevalin | “patients receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 Zevalin®) IV over 10 minutes on day 8.” NCT00070447 ↗ |
| Known as | yttrium-90 ibritumomab tiuxetan | “Pilot trial of yttrium-90 ibritumomab tiuxetan consolidation following” PMID 22035417 ↗ Dec 2011 |
| Known as | Zevalin | “Ibritumomab tiuxetan ("Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to the chelating agent tiuxetan.” NCT00850512 ↗27“Ibritumomab tiuxetan (Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to the chelating agent tiuxetan.” NCT00859001 ↗ “followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky diffuse large B cell lymphoma” NCT01157988 ↗ “2. Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14.” NCT00644371 ↗ “Ibritumomab Tiuxetan(Zevalin): 0.4 mCi/kg IV at day -14 (Day 0 is the transplantation)” NCT00607854 ↗ “Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg” NCT00662948 ↗ “standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy” NCT00689169 ↗ “a single course of IDEC-Y2B8 (90Y-ibritumomab tiuxetan, Zevalin)” NCT00186589 ↗ “with 90Y-ibritumomab tiuxetan (Zevalin®) in patients” NCT00722930 ↗ “Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)” NCT00386321 ↗ “Ibritumomab Tiuxetan (Zevalin) + Rituximab” NCT00582166 ↗ |
| Action | Deplete | “It is used to deliver radiation therapy to kill lymphoma cells.” NCT00005592 ↗ |
| Modality | Monoclonal antibody | “90Y Zevalin and 111In Zevalin are murine-based antibodies combined with a radioactive agent that can also destroy lymphoma cells.” NCT00048737 ↗ |
| Route | Intravenous | “This is a one time intravenous infusion for eligible patients” NCT00005592 ↗ |