Difference between revisions of "Necitumumab (Portrazza)"
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| − | = | + | ==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.<ref name=insert>[http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf Necitumumab (Portrazza) package insert]</ref><ref>[[:File:Necitumumab.pdf|Necitumumab (Portrazza) package insert (locally hosted backup)]]</ref><ref>[http://portrazza.com/ Portrazza manufacturer's website]</ref> | |
| + | <br>Route: IV | ||
| + | <br>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.<ref name="insert"></ref> |
| − | [[Category: | + | |
| − | [[Category:Intravenous | + | ==Diseases for which it is used== |
| + | *[[Non-small cell lung cancer, squamous]] | ||
| + | |||
| + | ==Patient drug information== | ||
| + | *Brief patient counseling information can be found in the [http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf Necitumumab (Portrazza) package insert]<ref name="insert"></ref> | ||
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | *2015-11-24: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm474278.htm FDA approved] to be used in combination with [[Gemcitabine (Gemzar)|gemcitabine]] and [[Cisplatin (Platinol)|cisplatin]], for first-line treatment of patients with metastatic [[Non-small cell lung cancer, squamous|squamous non-small cell lung cancer]]. ''(Based on SQUIRE)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *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 | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2017-03-16: Initial notice of compliance | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2019-06-18: Newly indicated for the treatment of unresectable advanced or recurrent [[Non-small cell lung cancer, squamous|squamous non-small cell lung cancer]]. | ||
| + | ==Also known as== | ||
| + | *'''Code name:''' IMC-11F8 | ||
| + | *'''Brand name:''' Portrazza | ||
| + | |||
| + | ==References== | ||
| + | <references/> | ||
| + | |||
| + | [[Category:Drugs]] | ||
| + | [[Category:Intravenous medications]] | ||
| − | |||
[[Category:Anti-EGFR antibodies]] | [[Category:Anti-EGFR antibodies]] | ||
| − | [[Category: | + | [[Category:Non-small cell lung cancer, squamous medications]] |
| + | [[Category:FDA approved in 2015]] | ||
| + | [[Category:EMA approved in 2016]] | ||
| + | [[Category:EMA withdrawn in 2021]] | ||
| + | [[Category:Health Canada approved in 2017]] | ||
| + | [[Category:PMDA approved in 2019]] | ||
Latest revision as of 00:09, 6 July 2024
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, 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
History of changes in PMDA indication
- 2019-06-18: Newly indicated for the treatment of unresectable advanced or recurrent squamous non-small cell lung cancer.
Also known as
- Code name: IMC-11F8
- Brand name: Portrazza