Difference between revisions of "Enfortumab vedotin (Padcev)"

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==General information==
 
==General information==
Class/mechanism from the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-nectin-4-antibody-drug-conjugate-asg-22ce NCI Drug Dictionary]: An antibody drug conjugate (ADC) containing a human monoclonal antibody AGS-22 targeting the cell adhesion molecule nectin-4 and conjugated to the cytotoxic agent monomethyl auristatin E (MMAE), via a proprietary enzyme-cleavable linker (AGS-22CE), with potential antineoplastic activity. The monoclonal antibody moiety of AGS-22CE selectively binds to nectin-4. After internalization and proteolytic cleavage, MMAE binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces apoptosis in nectin-4 overexpressing tumor cells.
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Class/mechanism from the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-nectin-4-antibody-drug-conjugate-asg-22ce NCI Drug Dictionary]: An antibody drug conjugate (ADC) containing a human monoclonal antibody AGS-22 targeting the cell adhesion molecule nectin-4 and conjugated to the cytotoxic agent monomethyl auristatin E (MMAE), via a proprietary enzyme-cleavable linker (AGS-22CE), with potential antineoplastic activity. The monoclonal antibody moiety of AGS-22CE selectively binds to nectin-4. After internalization and proteolytic cleavage, MMAE binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces apoptosis in nectin-4 overexpressing tumor cells. <ref name="insert">[https://astellas.us/docs/PADCEV_label.pdf Enfortumab vedotin (Padcev) package insert]</ref><ref>[[Media:Enfortumabvedotin.pdf | Enfortumab vedotin (Padcev) package insert (locally hosted backup)]]</ref><ref>[https://www.padcev.com/ Padcev 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. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], Medscape,[http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.
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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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://reference.medscape.com/drug/zytiga-abiraterone-999651 Medscape], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
 
*[[Bladder cancer]]
 
*[[Bladder cancer]]
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==Patient drug information==
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*[https://astellas.us/docs/PADCEV_label.pdf Enfortumab vedotin (Padcev) package insert]<ref name="insert"></ref>
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*[https://chemocare.com/chemotherapy/drug-info/enfortumab-vedotin.aspx Enfortumab vedotin (Padcev) patient drug information (Chemocare)]<ref>[https://chemocare.com/chemotherapy/drug-info/enfortumab-vedotin.aspx Enfortumab vedotin (Padcev) patient drug information (Chemocare)]</ref>
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*[https://www.uptodate.com/contents/enfortumab-vedotin-drug-information Enfortumab vedotin (Padcev) patient drug information (UpToDate)]<ref>[https://www.uptodate.com/contents/enfortumab-vedotin-drug-information Enfortumab vedotin (Padcev) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
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*'''Generic name:''' enfortumab vedotin-ejfv
 
*'''Generic name:''' enfortumab vedotin-ejfv
 
*'''Brand name:''' Padcev
 
*'''Brand name:''' Padcev
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==References==
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<references/>
  
 
[[Category:Drugs]]
 
[[Category:Drugs]]

Revision as of 20:32, 3 October 2020

General information

Class/mechanism from the NCI Drug Dictionary: An antibody drug conjugate (ADC) containing a human monoclonal antibody AGS-22 targeting the cell adhesion molecule nectin-4 and conjugated to the cytotoxic agent monomethyl auristatin E (MMAE), via a proprietary enzyme-cleavable linker (AGS-22CE), with potential antineoplastic activity. The monoclonal antibody moiety of AGS-22CE selectively binds to nectin-4. After internalization and proteolytic cleavage, MMAE binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces apoptosis in nectin-4 overexpressing tumor cells. [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, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  • 12/18/2019: Granted accelerated approval for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

Also known as

  • Code name: ASG-22CE
  • Generic name: enfortumab vedotin-ejfv
  • Brand name: Padcev

References