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tositumomab

Trade name: Bexxar

mAbapprovedADCOrphan Drug FDA

Approved

Jun 27, 2003

Tositumomab is a murine monoclonal antibody which targets the CD20 antigen produced in mammalian cell. It was combined with iodine-131 to produce a radiopharmaceutical for unsealed source radiotherapy, Iodine-131 Tositumomab, for the treatment of non-Hodgkins lymphoma. It is classified as a IgG2a lambda antibody. — Wikipedia

Clinical trial activity

33 trials · 24 clinical orgs · 2 marketing orgs

Phase 1
5
Phase 2
28
Phase 3
5
Phase 4
0

Earliest trial started Apr 1, 1990 (NCT01536561)

Timeline

1990s

  1. Jan 1, 1990

    GlaxoSmithKline — Earliest Phase 1 Sponsor(trial)

  2. May 16, 1994

    Orphan Drug Designation

  3. Jan 1, 1995

    GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jun 27, 2003

    Corixa — Earliest FDA Approval

  2. Jun 27, 2003

    Corixa — NDA Organization

  3. Jun 27, 2003

    GlaxoSmithKline — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 27, 2003

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No
Payload
131-iodine

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 131i anti-b1
  • 131i-anti-b1
  • 131i-anti-b1
  • 131i tositumomab
  • 131i tositumomab
  • 131i-tositumomab
  • anti-b1 antibody i-131
  • bexxar
  • bexxar
  • bexxar
  • bexxar
  • bexxar
  • i-131 anti-b1 antibody
  • i-131 tositumomab
  • iodine-131 anti-b1 antibody
  • iodine-131 anti-b1 monoclonal antibody
  • iodine (131i) tositumomab
  • iodine-131-labeled anti-cd20 antibody
  • iodine-131 tositumomab
  • iodine-131 tositumomab
  • iodine-131 tositumomab
  • iodine-131-tositumomab
  • iodine i 131 tositumomab
  • tositumomab
  • tositumomab
  • tositumomab
  • tositumomab
  • tositumomab
  • tositumomab conjugate with 131i
  • tositumomab i-131
  • tositumomab i-131
  • tositumomab i-131
  • tositumomab iodine-131

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT01389076Phase 2Jul 1, 2011GlaxoSmithKline, University of Michigan
NCT00770224Phase 2Apr 1, 2009National Cancer Institute (NCI), New York University, Southwest Oncology Group, University of Arizona, University of Washington
NCT00777114Phase 1Oct 1, 2008Cornell University, GlaxoSmithKline, Millennium Pharmaceuticals
NCT00475332Phase 2Sep 1, 2007GlaxoSmithKline, University of Florida
NCT00484874Phase 1/Phase 2 (Phase 2)Jun 1, 2007GlaxoSmithKline, Johns Hopkins University
NCT00479167Phase 2May 1, 2007GlaxoSmithKline, Millennium Pharmaceuticals, Rush University
NCT00434629Phase 1Feb 1, 2007GlaxoSmithKline, University of Pennsylvania
NCT00476047Phase 2Feb 1, 2007National Cancer Institute (NCI), University of Washington
NCT00490490Phase 2Jan 1, 2007GlaxoSmithKline, Stanford University
NCT00416312N/AJul 1, 2006Johns Hopkins University, National Cancer Institute (NCI)
NCT00329030Phase 3Dec 1, 2005Blood and Marrow Transplant Clinical Trials Network, Center for International Blood and Marrow Transplant Research, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)
NCT00107380Phase 2Nov 1, 2005National Cancer Institute (NCI), New York University, Southwest Oncology Group
NCT00577629Phase 2Jun 18, 2005Duke University, GlaxoSmithKline
NCT00268983Phase 3Oct 1, 2004GlaxoSmithKline
NCT00490009Phase 2Sep 1, 2004Corixa, GlaxoSmithKline, Stanford University
NCT00078598Phase 3Apr 1, 2004Corixa
NCT00240565Phase 2Apr 1, 2004GlaxoSmithKline
NCT00992992Phase 2Jun 1, 2001GlaxoSmithKline
NCT00006721Phase 3Mar 1, 2001Cancer and Leukemia Group B (CALGB), Eastern Cooperative Oncology Group, National Cancer Institute (NCI), Southwest Oncology Group, Stanford University, State University of New York, Buffalo, University of Washington
NCT01868035Phase 2May 1, 2000GlaxoSmithKline
Showing 20 of 33 trials
Page 1 / 2

Organizations

Research & Development (24)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit211231990
National Cancer Institute (NCI)Government9031998
University of WashingtonAcademic/Hospital5221999
Southwest Oncology GroupAcademic/Hospital4421999
Stanford UniversityAcademic/Hospital3222001
University of NebraskaAcademic/Hospital3331996
CorixaFor profit2122004
Johns Hopkins UniversityAcademic/Hospital2222006
Millennium PharmaceuticalsFor profit2022007
New York UniversityAcademic/Hospital2012005
Blood and Marrow Transplant Clinical Trials NetworkAcademic/Hospital1012005
Cancer and Leukemia Group B (CALGB)Academic/Hospital1012001
Center for International Blood and Marrow Transplant ResearchGovernment1012005
Cornell UniversityAcademic/Hospital1112008
Coulter PharmaceuticalFor profit1011998
Duke UniversityAcademic/Hospital1112005
Eastern Cooperative Oncology GroupAcademic/Hospital1012001
National Heart, Lung, and Blood Institute (NHLBI)Government1112005
Rush UniversityAcademic/Hospital1112007
State University of New York, BuffaloAcademic/Hospital1012001
24 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
CorixaFor profitNDAJun 27, 2003
GlaxoSmithKlineFor profitNDA2Jun 27, 2003