Difference between revisions of "Panitumumab (Vectibix)"
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==General information== | ==General information== | ||
| − | Class/mechanism: EGFR antagonist; recombinant human IgG2 kappa monoclonal antibody that binds to EGFR (human epidermal growth factor receptor), competitively inhibiting binding of epidermal growth factor (EGF). EGFR is overexpressed in certain cancers, such as colon & rectal cancer, and plays a role in the signal transduction pathways that lead to transcription of genes that promote cell growth, survival, and motility. Blocking EGFR in a population overexpressing EGFR has been observed to inhibit cell growth and induce apoptosis.<ref name="insert">[http://pi.amgen.com/united_states/vectibix/vectibix_pi.pdf Panitumumab (Vectibix) package insert]</ref><ref>[[ | + | Class/mechanism: EGFR antagonist; recombinant human IgG2 kappa monoclonal antibody that binds to EGFR (human epidermal growth factor receptor), competitively inhibiting binding of epidermal growth factor (EGF). EGFR is overexpressed in certain cancers, such as colon & rectal cancer, and plays a role in the signal transduction pathways that lead to transcription of genes that promote cell growth, survival, and motility. Blocking EGFR in a population overexpressing EGFR has been observed to inhibit cell growth and induce apoptosis.<ref name="insert">[http://pi.amgen.com/united_states/vectibix/vectibix_pi.pdf Panitumumab (Vectibix) package insert]</ref><ref>[[:File:Panitumumab.pdf | Panitumumab (Vectibix) package insert (locally hosted backup)]]</ref><ref>[http://www.vectibix.com/ Vectibix manufacturer's website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <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. | + | 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> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | *[[ | + | *[[Colorectal cancer]] |
| − | *[[ | + | *[[Head and neck cancer]] |
| − | *[[ | + | *[[Penile cancer]] |
==Patient drug information== | ==Patient drug information== | ||
| Line 19: | Line 17: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | * 2006-09-27: Accelerated FDA approval for the treatment of [[Biomarkers#EGFR_protein|EGFR]]-[[Biomarkers#expression|expressing]], metastatic [[colorectal cancer|colorectal carcinoma]] with disease progression on or following [[Regimen_classes#Fluoropyrimidine-based_regimen|fluoropyrimidine-]], [[Regimen_classes#Oxaliplatin-based_regimen|oxaliplatin-]], and [[Regimen_classes#Irinotecan-based_regimen|irinotecan-]] containing chemotherapy regimens. ''(Based on 20020408)'' |
| − | * | + | * 2009-07-17: Restriction placed: '''not indicated''' for the treatment of patients with KRAS mutation-positive mCRC or for whom KRAS mCRC status is unknown. ''(Based on 20100007 and PRIME)'' |
| − | * | + | * 2014-05-23: Full approval for the treatment of [[Biomarkers#Wild-type|wild-type]] [[Biomarkers#KRAS|KRAS]] ([[Biomarkers#Exon_2|exon 2]]) metastatic [[colorectal cancer]] (mCRC) in combination with [[Colon_cancer#FOLFOX_.26_Panitumumab|FOLFOX]] for first-line treatment. ''(Based on PRIME)'' |
| − | + | * 2014-05-23: Full approval for the treatment of [[Biomarkers#Wild-type|wild-type]] [[Biomarkers#KRAS|KRAS]] ([[Biomarkers#Exon_2|exon 2]]) metastatic [[colorectal cancer]] (mCRC) as monotherapy following disease progression after prior treatment with [[Regimen_classes#Fluoropyrimidine-based_regimen|fluoropyrimidine-]], [[Regimen_classes#Oxaliplatin-based_regimen|oxaliplatin-]], and [[Regimen_classes#Irinotecan-based_regimen|irinotecan-]] containing chemotherapy. ''(Based on 20100007 and ASPECCT)'' | |
| − | # | + | |
| − | + | ==History of changes in EMA indication== | |
| + | *2007-12-03: Initial authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2008-04-03: Initial notice of compliance with conditions | ||
| + | *2015-02-19: Conditions were met | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2010-04-16: Initial approval for the treatment of unresectable, advanced or recurrent [[colorectal cancer]] with wild-type KRAS. | ||
| + | ==Also known as== | ||
| + | *'''Generic names:''' ABX-EGF, clone E7.6.3 | ||
| + | *'''Brand name:''' Vectibix | ||
| + | |||
==References== | ==References== | ||
<references/> | <references/> | ||
| − | [[Category: | + | [[Category:Drugs]] |
| − | [[Category: | + | [[Category:Intravenous medications]] |
| − | [[Category: | + | [[Category:Mutation-specific medications]] |
| − | [[Category: | + | [[Category:Protein expression-specific medications]] |
| − | [[Category:EGFR | + | |
| + | [[Category:Anti-EGFR antibodies]] | ||
| − | [[Category: | + | [[Category:Colorectal cancer medications]] |
| + | [[Category:Head and neck cancer medications]] | ||
[[Category:Penile cancer medications]] | [[Category:Penile cancer medications]] | ||
| − | |||
| − | [[Category: | + | [[Category:FDA approved in 2006]] |
| + | [[Category:EMA approved in 2007]] | ||
| + | [[Category:Health Canada approved in 2008]] | ||
| + | [[Category:PMDA approved in 2010]] | ||
Latest revision as of 00:07, 6 July 2024
General information
Class/mechanism: EGFR antagonist; recombinant human IgG2 kappa monoclonal antibody that binds to EGFR (human epidermal growth factor receptor), competitively inhibiting binding of epidermal growth factor (EGF). EGFR is overexpressed in certain cancers, such as colon & rectal cancer, and plays a role in the signal transduction pathways that lead to transcription of genes that promote cell growth, survival, and motility. Blocking EGFR in a population overexpressing EGFR has been observed to inhibit cell growth and induce apoptosis.[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
- Panitumumab (Vectibix) patient drug information (Chemocare)[4]
- Brief patient counseling information can be found on page 15 of the Panitumumab (Vectibix) package insert[1]
- Panitumumab (Vectibix) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2006-09-27: Accelerated FDA approval for the treatment of EGFR-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens. (Based on 20020408)
- 2009-07-17: Restriction placed: not indicated for the treatment of patients with KRAS mutation-positive mCRC or for whom KRAS mCRC status is unknown. (Based on 20100007 and PRIME)
- 2014-05-23: Full approval for the treatment of wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) in combination with FOLFOX for first-line treatment. (Based on PRIME)
- 2014-05-23: Full approval for the treatment of wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy. (Based on 20100007 and ASPECCT)
History of changes in EMA indication
- 2007-12-03: Initial authorization
History of changes in Health Canada indication
- 2008-04-03: Initial notice of compliance with conditions
- 2015-02-19: Conditions were met
History of changes in PMDA indication
- 2010-04-16: Initial approval for the treatment of unresectable, advanced or recurrent colorectal cancer with wild-type KRAS.
Also known as
- Generic names: ABX-EGF, clone E7.6.3
- Brand name: Vectibix