Difference between revisions of "Ofatumumab (Arzerra)"
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| − | '''Note: As of 10 | + | '''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== | ==General information== | ||
| Line 25: | Line 25: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *10 | + | *2009-10-26: Granted accelerated approval for the treatment of patients with [[Chronic lymphocytic leukemia|chronic lymphocytic leukemia (CLL)]] refractory to [[Fludarabine (Fludara)]] and [[Alemtuzumab (Campath)]]. ''(Based on Hx-CD20-406)'' |
| − | * | + | *2014-04-17: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm393823.htm Approved] in combination with [[Chlorambucil (Leukeran)]], for the treatment of previously untreated patients with [[Chronic lymphocytic leukemia|chronic lymphocytic leukemia (CLL)]], for whom [[Fludarabine (Fludara)|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|chronic lymphocytic leukemia (CLL)]]. ''(Based on PROLONG)'' |
| − | * | + | *2016-08-30: Approved in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed [[Chronic lymphocytic leukemia|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== | ==History of changes in EMA indication== | ||
| − | * | + | *2010-04-19: Initial authorization as Arzerra |
| − | * | + | *2019-02-28: Approval withdrawn at the request of the manufacturer, for commercial reasons |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 | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' HuMax-CD20 | *'''Code name:''' HuMax-CD20 | ||
| Line 55: | Line 58: | ||
[[Category:FDA approved in 2009]] | [[Category:FDA approved in 2009]] | ||
[[Category:EMA approved in 2010]] | [[Category:EMA approved in 2010]] | ||
| + | [[Category:Health Canada approved in 2012]] | ||
[[Category:EMA withdrawn in 2019]] | [[Category:EMA withdrawn in 2019]] | ||
Revision as of 14:25, 29 March 2023
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).[1][2][3]
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, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Diseases for which it was used
Patient drug information
- Ofatumumab (Arzerra) patient drug information (Chemocare)[4]
- Patient counseling information can be found in the Ofatumumab (Arzerra) package insert[1]
- Ofatumumab (Arzerra) patient drug information (UpToDate)[5]
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: Approved 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
- 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
Also known as
- Code name: HuMax-CD20
- Brand names: Arzerra, Kesimpta
References
Categories:
- Drugs
- Intravenous medications
- Anti-CD20 antibodies
- Chronic lymphocytic leukemia medications
- Diffuse large B-cell lymphoma medications
- Follicular lymphoma medications
- Hodgkin lymphoma medications
- Waldenström macroglobulinemia medications (historic)
- FDA approved in 2009
- EMA approved in 2010
- Health Canada approved in 2012
- EMA withdrawn in 2019