Ofatumumab
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.
Overview
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 The EU granted conditional authorisation in 2010; the marketing authorisation was later withdrawn for commercial reasons and Arzerra is now supplied in many countries through a compassionate programme, while Kesimpta (subcutaneous ofatumumab) is marketed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.
- AmivantamabApproved
- CamizestrantApproved
- Comprehensive genomic profilingStandard of care
- Liquid biopsy (ctDNA)Standard of care
- LorlatinibApproved
- MRD / molecular residual disease testingEstablished
- ADC payload neutralisersPhase 1
- BGB-16673Phase 3
- Bispecific ADCPhase 3
- BRUIN CLL-321Positive
- CaDAnCe-304Recruiting
- CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)Active
- A clone report from blood at every treatment cycle
- A fast route to the matched drug when it is licensed for another cancer
- A multi-cancer platform trial of adaptive (dose-holiday) therapy
- A national rapid research autopsy network for end-stage cancer
- A standard evolvability score for every tumour
- A standing platform trial that assigns treatment by how the tumour escaped
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance atlas: how tumours escape and what closes the route · Lines of therapy.
Approvals
| 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| EU | 2010 | CLL refractory to fludarabine and alemtuzumab (conditional; authorisation since withdrawn) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
Pages like this
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