Ibritumomab Tiuxetan Overview
Introduction of ibritumomab tiuxetan
Ibritumomab tiuxetan is an antibody drug that consists in a monoclonal mouse IgG1 antibody ibritumomab and a chelator tiuxetan. The radioactive isotope yttrium-90 or indium-111 is added to the chelator tiuxetan, which is a modified version of diethylenetriamine pentaacetic acid (DTPA) whose carbon backbone contains an isothiocyanatobenzyl and a methyl group. This drug is directed against CD20 antigen, which is found on the surface of normal and malignant B cells (but not B cell precursors). This drug is developed by the IDEC Pharmaceuticals, now part of Biogen IdecIn. 2002, ibritumomab tiuxetan was approved by the Drug Administration (FDA) for the treatment of relapsed or refractory, low grade or transformed B cell non-Hodgkin's lymphoma under the trade name Zevalin. In 2004, ibritumomab tiuxetan was approved by European Medicines Agency and the U.S. Food for the treatment of follicular lymphoma under the trade name Zevalin. Ibritumomab tiuxetan was also marketed in Japan and Canada under the trade name Zevalin in 2008 and 2016 to treat B-cell non-Hodgkin's lymphoma, a lymphoproliferative disorder.
Mechanism of Action of ibritumomab tiuxetan
The active substance in ibritumomab tiuxetan, ibritumomab, is a monoclonal antibody composed of two murine gamma 1 heavy chains of 445 amino acids each and two kappa light chains of 213 amino acids each and is designed to target an antigen, CD20. Radioactive element Indium or yttrium conjugated murine IgG1 kappa monoclonal antibody destroy the cell via production of beta particles when the Fab segment of the antibody binds to the CD20 epitope on B-cells. In addition, the antibody itself can cause cell death through antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and apoptosis. B cells are cleared from the body by the combination of antibodies and reflexive elements, but since there is no CD antigen in stem cells, healthy B cells can regenerate after treatment.
Fig.1 Mechanism of action of ibritumomab tiuxetan
Table 1. Clinical Projects of Ibritumomab tiuxetan*
| NCT ID | Status | Condition | Lead Sponsor | Update Time |
| NCT00732498 | Active, not recruiting | Lymphoma; | University of Arizona | October 15, 2018 |
| NCT02320292 | Recruiting | Stage I Grade 1 Follicular Lymphoma; Stage I Grade 2 Follicular Lymphoma; Stage II Grade 1 Contiguous Follicular Lymphoma; Stage II Grade 1 Non-Contiguous Follicular Lymphoma; Stage II Grade 2 Contiguous Follicular Lymphoma; Stage II Grade 2 Non-Contiguous Follicular Lymphoma; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; | Mayo Clinic | February 6, 2018 |
| NCT00058422 | Active, not recruiting | Lymphoma; | Memorial Sloan Kettering Cancer Center | March 2, 2018 |
| NCT01434472 | Recruiting | Post-Transplant Lymphoproliferative Disorder; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent B-Cell Non-Hodgkin Lymphoma; Recurrent Burkitt Lymphoma; Refractory B-Cell Non-Hodgkin Lymphoma; Refractory Burkitt Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; | Fred Hutchinson Cancer Research Center | October 10, 2018 |
| NCT01811368 | Recruiting | Refractory Non Hodgkin Lymphoma; Relapsed Non Hodgkin Lymphoma; | University of California, Davis | March 2, 2018 |
| NCT00070018 | Active, not recruiting | Lymphoma; | Southwest Oncology Group | June 28, 2018 |
| NCT01490723 | Active, not recruiting | Leukemia; Lymphoma; | M.D. Anderson Cancer Center | November 8, 2018 |
| NCT01234766 | Active, not recruiting | Lymphoma, Follicular; | Dartmouth-Hitchcock Medical Center | September 18, 2018 |
| NCT00290511 | Active, not recruiting | Lymphoma; | M.D. Anderson Cancer Center | October 3, 2018 |
| NCT00577278 | Active, not recruiting | Graft Versus Host Disease; Leukemia; Lymphoma; | City of Hope Medical Center | November 6, 2018 |
| NCT00591630 | Active, not recruiting | Diffuse Large Cell Lymphoma; Lymphoma; | M.D. Anderson Cancer Center | November 8, 2018 |
| NCT01827605 | Recruiting | Relapsed Follicular Lymphoma; | Fondazione Italiana Linfomi ONLUS | May 22, 2018 |
| NCT01359592 | Active, not recruiting | Lymphoma; | Southwest Oncology Group | October 10, 2018 |
| NCT02063685 | Active, not recruiting | Follicular Non-Hodgkin's Lymphoma; | Fondazione Italiana Linfomi ONLUS | November 20, 2018 |
| NCT00889798 | Active, not recruiting | Non-Hodgkin's Lymphoma (NHL);Chronic Lymphocytic Leukemia (CLL);Multiple Myeloma (MM); | iOMEDICO AG | August 10, 2018 |
Table 2. Approved Drugs of ibritumomab+tiuxetan **
| INN (trade name) | Therapeutic area | Dose | Strength | Route | Company | Marketing start | Market |
| Zevalin | Low-grade or follicular B-cell NHL; Newly diagnosed follicular NHL | Kit for radiopharmaceutical preparations for infusion | 3.2mg/2ml | Intravenous infusion | Spectrum Pharms | February 19, 2002 |
|
| Zevalin | Lymphoma, Follicular | Kit for radiopharmaceutical preparations for infusion | 1.6 mg/ml | Intravenous infusion | Spectrum Pharmaceuticals B.V. | January 16, 2004 |
|
| Zevalin | CD20 positive recurrence or refractory disease; Low-grade B-cell non-Hodgkin's lymphoma, mantle cell lymphoma; | Yttrium Injection | 10 ml/vial | Intravenous infusion | Mundipharma Co., Ltd. | January 25, 2008 |
|
| Zevalin | Confirmation of accumulation site of ibritumomab tiuxetan | Indium Injection | 10 ml/vial | Intravenous infusion | Mundipharma Co., Ltd. | January 25, 2008 |
|
| Zevalin | B-cell non-Hodgkin's lymphoma | Kit for radiopharmaceutical preparations for infusion | 3.2mg/2ml | Intravenous infusion | Servier Canada Inc. | July 8, 2016 |
|
What We Provide
Therapeutic Antibody
Ibritumomab tiuxetan
We provide high-quality Ibritumomab tiuxetan for use in WB, FC, IP, ELISA, Neut, FuncS, IF and most other immunological methods. For lab research use only, not for diagnostic, therapeutic or any in vivo human use.
Reference
* The table was excerpted from the following website
https://clinicaltrials.gov/ct2/results?term=ibritumomab+tiuxetan
** Information presented in the table were collected from the following website:https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125019
https://www.ema.europa.eu/en/medicines/human/EPAR/zevalin
For research use only. Not intended for any clinical use.
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