Difference between revisions of "Erlotinib (Tarceva)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *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> | + | *11/18/2004: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm209058.htm FDA approved] for "treatment of locally advanced or metastatic [[Non-small cell lung cancer | NSCLC]] after failure of at least one prior [[:Category:Chemotherapy | chemotherapy]] regimen."<ref name="insert"></ref> |
| − | *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> | + | *11/2/2005: FDA approved as "first-line treatment of patients with locally advanced, unresectable or metastatic [[Pancreatic cancer | pancreatic cancer]], in combination with [[Gemcitabine (Gemzar) | gemcitabine]]."<ref name="insert"></ref> |
| − | *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> | + | *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 | non-small cell lung cancer (NSCLC)]] whose disease has not progressed after four cycles of [[:Category:Platinum_agents | platinum-based]] first-line chemotherapy."<ref name="insert"></ref> |
| − | *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> | + | *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 | 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> |
==Also known as== | ==Also known as== | ||
| Line 33: | Line 33: | ||
[[Category:Drug index]] | [[Category:Drug index]] | ||
[[Category:Chemotherapy]] | [[Category:Chemotherapy]] | ||
| + | [[Category:Oral chemotherapy]] | ||
| + | |||
[[Category:Kinase inhibitors]] | [[Category:Kinase inhibitors]] | ||
[[Category:EGFR inhibitors]] | [[Category:EGFR inhibitors]] | ||
Revision as of 02:45, 17 November 2014
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
- Esophageal cancer
- Hepatobiliary cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Renal cancer
- Unknown primary
Patient drug information
- Erlotinib (Tarceva) patient drug information (Chemocare)[4]
- Brief patient counseling information can be found on page 24 of the Erlotinib (Tarceva) package insert[1]
- Erlotinib (Tarceva) patient drug information (UpToDate)[5]
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.