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Ofatumumab (Arzerra) is a fully human anti-CD20 antibody for chronic lymphocytic leukaemia, used with chlorambucil in untreated patients or alone after other drugs have failed; the same molecule is sold as Kesimpta for multiple sclerosis.
Ofatumumab received accelerated FDA approval in October 2009 for CLL refractory to fludarabine and alemtuzumab, then full approvals with chlorambucil in previously untreated CLL where fludarabine is inappropriate (COMPLEMENT-1, 2014: longer progression-free survival than chlorambucil alone), as extended treatment in recurrent or progressive CLL after response (PROLONG, 2016) and with fludarabine and cyclophosphamide in relapsed CLL (COMPLEMENT-2, 2016). The EU granted conditional authorisation in 2010; the marketing authorisation was later withdrawn for commercial reasons and Arzerra is now supplied in many countries through a compassionate programme, while Kesimpta (subcutaneous ofatumumab) is marketed for multiple sclerosis. Hepatitis B reactivation and progressive multifocal leukoencephalopathy carry boxed warnings.
Backbone ribbon from PDB 6Y92. RCSB PDB 6Y92. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Binds a distinct small- and large-loop epitope of CD20 close to the membrane, giving potent complement-dependent cytotoxicity as well as antibody-dependent cellular cytotoxicity against B cells. Connects to CD20.
1.Ofatumumab binds CD20.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
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Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab
Confirmed: the accelerated approval of 2009 converted to traditional approval 4.5 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 2009 | CLL refractory to fludarabine and alemtuzumab (accelerated) |
| US | 2014 | Previously untreated CLL with chlorambucil; later extended treatment and relapsed CLL with fludarabine and cyclophosphamide |
| EU | 2010 | CLL refractory to fludarabine and alemtuzumab (conditional; authorisation since withdrawn) |
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Query for this drug: (TITLE:"Ofatumumab" OR ABSTRACT:"Ofatumumab" OR TITLE:"Arzerra" OR ABSTRACT:"Arzerra" OR TITLE:"Kesimpta multiple sclerosis formulation" OR ABSTRACT:"Kesimpta multiple sclerosis formulation") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Ofatumumab, not a curated reading list.
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Shares Obinutuzumab, Chronic lymphocytic leukaemia, Monoclonal antibodies.
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