Ibritumomab tiuxetan

Overview

Indium or yttrium conjugated murine IgG1 kappa monoclonal antibody directed against the CD20 antigen, which is found on the surface of normal and malignant B lymphocytes. Ibritumomab is produced in Chinese hamster ovary cells and is composed of two murine gamma 1 heavy chains of 445 amino acids each and two kappa light chains of 213 amino acids each.

Indication

For treatment of non-Hodgkin's lymphoma

Associated Conditions

Follicular Non-Hodgkin's Lymphoma
Follicular Non-Hodgkin's Lymphoma Refractory
Relapsed follicular B-cell non-Hodgkin's lymphoma

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Evaluate the Efficacy of Response-adapted Strategy in Follicular Lymphoma	2014/02/14	NCT02063685	Phase 3	Completed	Fondazione Italiana Linfomi - ETS
Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta)	2012/08/10	NCT01662102	Phase 3	Terminated	Spectrum Pharmaceuticals, Inc
Y Zevalin and BEAM in Autologous Stem Cell Transplantation (ASCT) for Lymphoma	2012/02/24	NCT01538472	Phase 1	Completed	M.D. Anderson Cancer Center
Study of Zevalin Versus Observation in Participants at Least 60 Years Old With Newly Diagnosed Diffuse Large B-cell Lymphoma in Positron Emission Tomography (PET)-Negative Complete Remission After Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like Therapy	2012/01/13	NCT01510184	Phase 3	Terminated	Spectrum Pharmaceuticals, Inc
Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as an Initial Therapy of Follicular Lymphoma	2011/12/16	NCT01493479	Phase 2	Completed	The Christie NHS Foundation Trust
Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT)	2011/12/13	NCT01490723	Phase 2	Completed	M.D. Anderson Cancer Center
Zevalin for Patients With Incomplete Response to Chemo Prior to Autologous Stem Cell Transplant for Multiple Myeloma	2010/09/23	NCT01207765	Phase 2	Terminated	Tufts Medical Center
90Y-ibritumomab Tiuxetan Consolidation After 6th R-CHOP Chemotherapy in Patients With Bulky Diffuse Large B Cell Lymphoma	2010/07/08	NCT01157988	Phase 2	Completed	Chonnam National University Hospital
Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) Study in Patients With Follicular Grade I-II Lymphoma After 4 Cycles of Fludarabine-Mitoxantrone-Rituximab (FMR) Therapy	2009/03/10	NCT00859001	Phase 2	Completed	University of Bologna
Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) in Elderly (More Than 60 Years) Patients With Diffuse Large B Cell Lymphoma After 4 Cycles of CHOP21-Rituximab (CHOP21-R) Therapy	2009/02/25	NCT00850512	Phase 2	Completed	University of Bologna

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Zevalin	Ceft Biopharma s.r.o.,Trtinova 260/1,Cakovice, 196 00 Praha 9,Czech Republic	Lapsed	1/16/2004

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

WuXi AppTec Predicts Shift from Antibodies to Peptides in Radiopharmaceutical Development

10 months ago

• WuXi AppTec's VP Dr. Dave Madge highlights potential transition from antibody-based to peptide-based radiotherapeutics, citing advantages in tissue penetration and reduced toxicity. • Major pharmaceutical companies including Bristol Myers Squibb, Novartis, and Eli Lilly have made significant investments in radiopharmaceuticals, with deals ranging from $1.4B to $4.2B. • WuXi AppTec expands peptide manufacturing capacity with two new facilities in China, responding to growing global demand despite potential challenges from US BIOSECURE Act.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access