Ofatumumab (Arzerra)

Note: As of 2020-10-15, ofatumumab is no longer available for commercial purchase as Arzerra. Novartis will continue providing drug directly, at no cost to patient, but only for the diagnosis of chronic lymphocytic leukemia.

General information

Class/mechanism: Anti-CD20 monoclonal antibody that binds to small and large extracellular loops of the CD20 molecule which is expressed on B-cells. The Fc domain of ofatumumab has been observed in vitro to mediate immune effector functions and B-cell lysis, which is hypothesized to involve complement-dependent cytotoxicity (CDC) and/or antibody-dependent cell mediated cytotoxicity (ADCC).
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information.

Diseases for which it is used

• Chronic lymphocytic leukemia
• Diffuse large B-cell lymphoma
• Follicular lymphoma
• Classical Hodgkin lymphoma

Diseases for which it was used

• Waldenström macroglobulinemia

Patient drug information

• Ofatumumab (Arzerra) patient drug information (Chemocare)
• Patient counseling information can be found in the Ofatumumab (Arzerra) package insert
• Ofatumumab (Arzerra) patient drug information (UpToDate)

History of changes in FDA indication

• 2009-10-26: Granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to Fludarabine (Fludara) and Alemtuzumab (Campath). (Based on Hx-CD20-406)
  • 2014-04-17: Converted to full approval in combination with Chlorambucil (Leukeran), for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate. (Based on COMPLEMENT 1)
• 2016-01-19: Approval expanded for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). (Based on PROLONG)
• 2016-08-30: Approved in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL. (Based on COMPLEMENT 2)
• 2020-08-20: Approved as Kesimpta for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. (Non-cancer indication)

History of changes in EMA indication

• 2010-04-19: Initial authorization as Arzerra for treatment of chronic lymphocytic leukaemia (CLL) in patients refractory to fludarabine and alemtuzumab. (Based on Hx-CD20-406)
• 2014-06-30: Extension of Indication to include in previously untreated chronic lymphocytic leukaemia (CLL) patients, the treatment in combination with chlorambucil or bendamustine of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.
• 2016-12-08: Extension of indication to include the combination of Arzerra with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed Chronic Lymphocytic Leukaemia.
• 2019-02-28: Approval withdrawn at the request of the manufacturer, for commercial reasons

History of changes in Health Canada indication

• 2012-03-09: Initial notice of compliance with conditions
• 2017-01-17: Conditions were met

History of changes in PMDA indication

• 2013-03-25: Initial approval for the treatment of relapsed or refractory CD20-positive chronic lymphocytic leukemia.

Also known as

• Code name: HuMax-CD20
• Brand names: Arzerra, Kesimpta