Difference between revisions of "Necitumumab (Portrazza)"
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*2016-02-15: Initial authorization for the treatment of [[Non-small cell lung cancer, squamous|squamous non-small cell lung cancer]]. | *2016-02-15: Initial authorization for the treatment of [[Non-small cell lung cancer, squamous|squamous non-small cell lung cancer]]. | ||
*2021-02-18: Authorization withdrawn at the request of the manufacturer, for commercial reasons | *2021-02-18: Authorization withdrawn at the request of the manufacturer, for commercial reasons | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2017-03-16: Initial notice of compliance | ||
==Also known as== | ==Also known as== | ||
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[[Category:EMA approved in 2016]] | [[Category:EMA approved in 2016]] | ||
[[Category:EMA withdrawn in 2021]] | [[Category:EMA withdrawn in 2021]] | ||
| + | [[Category:Health Canada approved in 2017]] | ||
Revision as of 13:27, 11 May 2023
General information
Class/mechanism: Recombinant human IgG1 EGFR monoclonal antibody. Necitumumab binds to the human epidermal growth factor receptor (EGFR) prevents it from binding to its ligands. This interferes with EGFR's effects on growth of malignant cells, angiogenesis, and inhibition of apoptosis. In vitro, necitumumab has been observed to cause antibody-dependent cellular cytotoxicity (ADCC) in cells which express EGFR, induce the internalization of EGFR, and lead to its degradation.[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
Patient drug information
- Brief patient counseling information can be found in the Necitumumab (Portrazza) package insert[1]
History of changes in FDA indication
- 2015-11-24: FDA approved to be used in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. (Based on SQUIRE)
History of changes in EMA indication
- 2016-02-15: Initial authorization for the treatment of squamous non-small cell lung cancer.
- 2021-02-18: Authorization withdrawn at the request of the manufacturer, for commercial reasons
History of changes in Health Canada indication
- 2017-03-16: Initial notice of compliance
Also known as
- Code name: IMC-11F8
- Brand name: Portrazza