ibritumomab tiuxetan
Trade name: Zevalin
mAbapprovedADCOrphan Drug FDA
Approved
Feb 19, 2002
Ibritumomab tiuxetan, sold under the trade name Zevalin, is a monoclonal antibody radioimmunotherapy treatment for non-Hodgkin's lymphoma. The drug uses the monoclonal mouse IgG1 antibody ibritumomab in conjunction with the chelator tiuxetan, to which a radioactive isotope is added. Tiuxetan is a modified version of DTPA whose carbon backbone contains an isothiocyanatobenzyl and a methyl group. — Wikipedia
Clinical trial activity
104 trials · 92 clinical orgs · 4 marketing orgs
Phase 1
23
Phase 2
90
Phase 3
13
Phase 4
1
Earliest trial started Sep 1, 1998 (NCT00268203)
Timeline
1990s
2000s
- Jan 1, 2001
Earliest Phase 3 Sponsor(trial)
- Feb 1, 2002
Biogen-IDEC — First NDA Organization
- Feb 1, 2002
Biogen-IDEC — NDA Organization
- Feb 19, 2002
Earliest FDA Approval
- Feb 19, 2002
Acrotech Biopharma LLC — NDA Secondary Org
- Mar 16, 2009
Spectrum Pharmaceuticals — Marketing Organization
Indications
Studied for
- Bone Marrow Cells · Phase 1
- Burkitt Lymphoma · Phase 2
- Graft vs Host Disease · Phase 2
- Hodgkin Disease · Phase 2
- Leukemia · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia-Lymphoma, Adult T-Cell · Phase 2
- Lymphoma · Phase 3
- Lymphoma, AIDS-Related · Phase 2
- Lymphoma, B-Cell · Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 2
- Lymphoma, Follicular · Phase 3
- Lymphoma, Large B-Cell, Diffuse · Phase 3
- Lymphoma, Large-Cell, Anaplastic · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 4
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Early Phase 1
- Lymphomatoid Granulomatosis · Phase 2
- Multiple Myeloma · Phase 2
- Testicular Neoplasms · Phase 2
- Transplantation · Phase 2
- Waldenstrom Macroglobulinemia · Phase 2
Mechanism of action
- B-lymphocyte antigen CD20BINDING AGENT
MS4A1 binding agent
targets radiotherapy to cell(via tiuxetan)
- B-lymphocyte antigen CD20Radiopharmaceutical
MS4A1 radiopharmaceutical
Approval history
- approvedAcceleratedFeb 19, 2002
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
- Multi-specific
- No
- Payload
- 90-Yttrium
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaIbritumomab tiuxetan ↗
- NCATS4Q52C550XK ↗
- ChEMBLCHEMBL2108667 ↗
- ChEMBLCHEMBL1201606 ↗
Also known as
- 111in ibritumomab
- 111in ibritumomab tiuxetan
- 90y ibritumomab tiuxetan
- 90y-ibritumomab tiuxetan
- 90y zevalin
- 90y-zevalin
- bay-86-5128
- ibritumomab
- ibritumomab
- ibritumomab tiuxetan
- ibritumomab tiuxetan
- ibritumomab tiuxetan
- ibritumomab tiuxetan
- ibritumomab tiuxetan
- ibritumomab tiuxetan
- ibritumomab tiuxetan
- ibritumomab tiuxetan
- ibritumomab tiuxetan
- ibritumomab tiuxetan
- ibritumomab tiuxetan (90y)
- ibritumomab tiuxetan (90y)
- ibritumomab tiuxetan (90y)
- ibritumomab tiuxetan (90y)
- ibritumomab tiuxetan (90y)
- idec-129
- idec-in2b8
- idec-y2b8
- idec-y2b8
- idec-y2b8
- idec-y2b8
- idec-y2b8 idec-129
- in111 ibritumomab tiuxetan
- in111-ibritumomab tiuxetan
- mab murine (igg1) anti p19437 (cd20_mouse)
- y90 ibritumomab
- y90 ibritumomab tiuxetan
- yttrium-90 ibritumomab tiuxetan
- yttrium-90 ibritumomab tiuxetan
- yttrium-90-ibritumomab tiuxetan
- yttrium y 90 ibritumomab tiuxetan
- zevalin
- zevalin
- zevalin
- zevalin
- zevalin
- zevalin
- zevalin kit-indium-111
- zevalline
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02320292 | Phase 3 | Feb 1, 2015 | Mayo Clinic, National Cancer Institute (NCI) |
| NCT02366663 | Phase 3 | Jan 1, 2015 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT01973062 | Phase 2 | Mar 1, 2014 | Case Western Reserve University, National Cancer Institute (NCI) |
| NCT01811368 | Phase 2 | Mar 1, 2013 | Spectrum Pharmaceuticals, University of California, Davis |
| NCT01490723 | Phase 2 | Jan 1, 2013 | Spectrum Pharmaceuticals, University of Texas at Houston |
| NCT01662102 | Phase 3 | Sep 1, 2012 | 21st Century Oncology, Mayo Clinic, Northeast Georgia Cancer Care, Spectrum Pharmaceuticals, University of Texas at Houston, US Oncology, West Virginia University |
| NCT01686165 | Phase 2 | Aug 31, 2012 | National Cancer Institute (NCI), University of Arizona |
| NCT02063685 | Phase 3 | Jul 1, 2012 | Fondazione Italiana Diabete Onlus, University of Messina, University of Modena and Reggio Emilia |
| NCT01510184 | Phase 3 | Apr 1, 2012 | Spectrum Pharmaceuticals |
| NCT01497275 | Phase 2 | Feb 1, 2012 | Duke University, Spectrum Pharmaceuticals |
| NCT01827605 | Phase 3 | Jan 1, 2012 | Fondazione Italiana Diabete Onlus |
| NCT01434472 | Phase 2 | Nov 16, 2011 | National Cancer Institute (NCI), University of Washington |
| NCT01549886 | Phase 2 | Nov 1, 2011 | Spectrum Pharmaceuticals, University of Massachusetts |
| NCT01359592 | Phase 2 | Sep 1, 2011 | National Cancer Institute (NCI), Southwest Oncology Group, Yale University |
| NCT01234766 | Phase 2 | Oct 1, 2010 | Cephalon, Dartmouth University, Spectrum Pharmaceuticals |
| NCT00859001 | Phase 2 | Mar 9, 2009 | University of Bologna |
| NCT00850512 | Phase 2 | Feb 24, 2009 | University of Bologna |
| NCT00662948 | Phase 2 | Dec 1, 2008 | Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea, PETHEMA Foundation, Universidad Autonoma de Madrid, University of Barcelona, University of Texas at Houston |
| NCT00807196 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2008 | Bayer, University of Montreal |
| NCT00722930 | Phase 2 | Apr 1, 2008 | Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas |
Showing 20 of 104 trials
Page 1 / 6
Organizations
Research & Development (92)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 32 | 7 | 4 | 1999 |
| Biogen | For profit | 17 | 2 | 5 | 1999 |
| University of Texas at Houston | Academic/Hospital | 11 | 9 | 3 | 2002 |
| Bayer | For profit | 10 | 2 | 2 | 2001 |
| Spectrum Pharmaceuticals | For profit | 9 | 4 | 2 | 2006 |
| City of Hope National Medical Center | Academic/Hospital | 5 | 4 | 2 | 1999 |
| GlaxoSmithKline | For profit | 5 | 4 | 2 | 1998 |
| Mayo Clinic | Academic/Hospital | 5 | 3 | 3 | 2001 |
| University of Washington | Academic/Hospital | 5 | 4 | 2 | 1999 |
| Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea | Academic/Hospital | 4 | 2 | 1 | 2006 |
| Northwestern University | Academic/Hospital | 4 | 3 | 2 | 2000 |
| CTI BioPharma | For profit | 3 | 1 | 2 | 2006 |
| Harvard University | Academic/Hospital | 3 | 3 | 1 | 2003 |
| University of Arizona | Academic/Hospital | 3 | 2 | 1 | 2004 |
| University of Brescia | Academic/Hospital | 3 | 1 | 2 | 2005 |
| AIDS Malignancy Consortium | Academic/Hospital | 2 | 1 | 1 | 2003 |
| Cornell University | Academic/Hospital | 2 | 2 | 2 | 2003 |
| Fondazione Italiana Diabete Onlus | Academic/Hospital | 2 | 2 | 1 | 2012 |
| Johns Hopkins University | Academic/Hospital | 2 | 1 | 2 | 2001 |
| SCRI Development Innovations | For profit | 2 | 2 | 1 | 2002 |
92 organizations
Page 1 / 5
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Acrotech Biopharma LLC | For profit | NDA2 | Feb 19, 2002 |
| Biogen-IDEC | For profit | NDA | Feb 1, 2002 |
| IDEC | For profit | IND | — |
| Spectrum Pharmaceuticals | For profit | MKTG | Mar 16, 2009 |