Arzerra (ofatumumab) 100 mg, for IV use, Glaxo, United Kingdom

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Ofatumumab

Description

An anticancer medication used to treat a type of cancer in the bone marrow.

Structure

DrugBank ID

DB06650

Modality

Protein Based Therapies:

Monoclonal antibody (mAb)

US Approved

YES

Other Approved

YES

Patents

2

Indicated Conditions

8

Clinical Trials

Phase 0

0

Phase 1

17

Phase 2

94

Phase 3

32

Phase 4

8

Therapeutic Categories

CD20-directed Cytolytic Antibody 

Mechanism of Action

B-lymphocyte antigen CD20AntibodyRegulator

Identification

Summary

Ofatumumab is an anti-CD20 antibody used for the treatment of chronic lymphocytic leukemia (CLL) in selected patients with certain treatment histories and responsiveness to anticancer medications.

Brand Names

Arzerra, Kesimpta

Generic Name

Ofatumumab

DrugBank Accession Number

DB06650

Background

Ofatumumab is a novel anti-CD20 monoclonal antibody that targets B-cells. It is an IgG1κ human monoclonal antibody produced from a recombinant murine cell line (NS0) via transgenic mouse and hybridoma technology.6 Ofatumumab works by recognizing antigens that are expressed on the tumour cells in certain cancers; however, the antigen is not tumour-specific and can also be found in normal B-cells.1 Ofatumumab was first approved by the FDA in 2009.8 It is used in the treatment of recurrent, progressive, or recurrent chronic lymphocytic leukemia (CLL) or CLL in treatment-naive patients in whom fludarabine-based therapy is considered inappropriate. Ofatumumab is used as monotherapy or in combination with other medications, depending on the patient profile and previous treatment history.6 Although it has a similar molecular mechanism of action as rituximab, another CD-20 monoclonal antibody used in the treatment of rheumatoid arthritis and B-cell non-Hodgkin's lymphoma, ofatumumab has a higher affinity towards CD20.1

Ofatumumab is available for intravenous administration and is marketed as Arzerra. In Phase III clinical trials consisting of subjects with relapsing forms of multiple sclerosis (RMS), subcutaneous administration of ofatumumab reduced the number of relapses and delayed disease progression. In February 2020, FDA and EMA approved Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of RMS in adults.7 The FDA subsequently approved ofatumumab for the treatment of RMS on August 20, 2020.9 The potential therapeutic use of ofatumumab in various lymphomas and rheumatoid arthritis has also been investigated.4

Modality

Protein Based Therapies

Monoclonal antibody (mAb)

Groups

Approved, Investigational

Protein Structure

Protein Chemical Formula

C6480H10022N1742O2020S44

Protein Average Weight

146100.0 Da

Sequences

>Ofatumumab Heavy Chain

EVQLVESGGGLVQPGRSLRLSCAASGFTFNDYAMHWVRQAPGKGLEWVSTISWNSGSIGY

ADSVKGRFTISRDNAKKSLYLQMNSLRAEDTALYYCAKDIQYGNYYYGMDVWGQGTTVTV

SSASTKGPSVFPLAPGSSKSTSGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ

SSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEP

>Ofatumumab Light Chain

EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPA

RFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPITFGQGTRLEIKRTVAAPSVFIFPP

SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT

LSKADYEKHKVYACEVTHQGLSSPVTKSFNR

Synonyms

HuMax-CD20

HuMax-CD20, 2F2

Ofatumumab

Ofatumumabum

External IDs 

GSK 1841157

GSK-1841157

GSK1841157

GSKI841157

HSDB 8170

OMB 157

OMB-157

OMB157

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Pharmacology

Indication

Ofatumumab is indicated, in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.6

In patients with recurrent or progressive CLL, ofatumumab is indicated for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.6

Ofatumumab is indicated for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.6

Ofatumumab is also indicated for the treatment of adult patients with relapsing forms of multiple sclerosis, including active secondary progressive disease, clinically isolated syndrome, and relapsing-remitting disease.9