Difference between revisions of "Erlotinib (Tarceva)"

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(FDA approval)
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Also known as Erlotinib hydrochloride.
 
 
 
==General information==
 
==General information==
Class/mechanism: Small molecule tyrosine kinase inhibitor.  Inhibits the intracellular phosphorylation activity of the epidermal growth factor receptor (EGFR) tyrosine kinase; may also have activity against other tyrosine kinase receptors.  Exact mechanism of antitumor action is not fully characterized.<ref name="insert">[http://www.gene.com/gene/products/information/pdf/tarceva-prescribing.pdf Erlotinib (Tarceva) package insert]</ref><ref>[[Media:Erlotinib.pdf | Erlotinib (Tarceva) package insert (locally hosted backup)]]</ref><ref>[http://tarceva.com Tarceva manufacturer's website]</ref>
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Class/mechanism: Small molecule tyrosine kinase inhibitor.  Inhibits the intracellular phosphorylation activity of the epidermal growth factor receptor (EGFR) tyrosine kinase; may also have activity against other tyrosine kinase receptors.  Exact mechanism of antitumor action is not fully characterized.<ref name="insert">[http://www.gene.com/gene/products/information/pdf/tarceva-prescribing.pdf Erlotinib (Tarceva) package insert]</ref><ref>[[Media:Erlotinib.pdf | Erlotinib (Tarceva) package insert (locally hosted backup)]]</ref><ref>[http://tarceva.com Tarceva manufacturer's website]</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>Extravasation: n/a
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*Brief patient counseling information can be found on [http://www.gene.com/gene/products/information/pdf/tarceva-prescribing.pdf#page=24 page 24 of the Erlotinib (Tarceva) package insert]<ref name="insert"></ref>
 
*Brief patient counseling information can be found on [http://www.gene.com/gene/products/information/pdf/tarceva-prescribing.pdf#page=24 page 24 of the Erlotinib (Tarceva) package insert]<ref name="insert"></ref>
 
*[http://www.uptodate.com/contents/erlotinib-patient-drug-information Erlotinib (Tarceva) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/erlotinib-patient-drug-information Erlotinib (Tarceva) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/erlotinib-patient-drug-information Erlotinib (Tarceva) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/erlotinib-patient-drug-information Erlotinib (Tarceva) patient drug information (UpToDate)]</ref>
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==History of changes in FDA indication==
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*11/18/2004: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm209058.htm FDA approved] for "treatment of locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen."<ref name="insert"></ref>
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*11/2/2005: FDA approved as "first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine."<ref name="insert"></ref>
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*4/16/2010: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm209058.htm FDA approved] "for maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy."<ref name="insert"></ref>
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*5/14/2013: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352230.htm FDA approved] for "first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test."<ref name="insert"></ref>
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==Also known as==
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Erlotinib hydrochloride.
  
 
==References==
 
==References==

Revision as of 02:39, 15 May 2013

General information

Class/mechanism: Small molecule tyrosine kinase inhibitor. Inhibits the intracellular phosphorylation activity of the epidermal growth factor receptor (EGFR) tyrosine kinase; may also have activity against other tyrosine kinase receptors. Exact mechanism of antitumor action is not fully characterized.[1][2][3]
Route: PO
Extravasation: n/a

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

History of changes in FDA indication

  • 11/18/2004: FDA approved for "treatment of locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen."[1]
  • 11/2/2005: FDA approved as "first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine."[1]
  • 4/16/2010: FDA approved "for maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy."[1]
  • 5/14/2013: FDA approved for "first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test."[1]

Also known as

Erlotinib hydrochloride.

References