Difference between revisions of "Erlotinib (Tarceva)"

Revision as of 00:27, 11 January 2020

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

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: Approved for treatment of locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.^[1]
11/2/2005: Approved as first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.^[1]
4/16/2010: 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: 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 deletion or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.^[1]
10/18/2016: Label revised to limit use to those patients whose tumors have EGFR exon 19 deletions or exon 21 L858R substitution mutations as detected by an FDA-approved test. This limitation pertains to patients with NSCLC receiving maintenance or second or greater line treatment.

Also known as

Code names: CP-358, CP-774, OSI-774
Generic name: erlotinib hydrochloride
Brand names: Erlocip, Erlonat, Melacyte, Tarceva

References

[insert-1] 1.0 ^1.1 ^1.2 ^1.3 ^1.4 ^1.5 ^1.6 Erlotinib (Tarceva) package insert

[2] Erlotinib (Tarceva) package insert (locally hosted backup)

[3] Tarceva manufacturer's website

[4] Erlotinib (Tarceva) patient drug information (Chemocare)

[5] Erlotinib (Tarceva) patient drug information (UpToDate)

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[2]

[3]

[4]

[5]

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 ==History of changes in FDA indication==
-*11/18/2004: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm209058.htm 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>
+*11/18/2004: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm209058.htm Approved] for treatment of locally advanced or metastatic [[Non-small cell lung cancer | NSCLC]] after failure of at least one prior chemotherapy regimen.<ref name="insert"></ref>
 *11/2/2005: 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 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 [[Regimen_classes#Platinum-based_regimen | platinum-based]] first-line chemotherapy.<ref name="insert"></ref>
-*5/14/2013: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352230.htm 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>
+*5/14/2013: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352230.htm Approved] for first-line treatment of patients with metastatic [[Non-small cell lung cancer | non-small cell lung cancer (NSCLC)]] whose tumors have [[Biomarkers#EGFR|epidermal growth factor receptor (EGFR)]] [[Biomarkers#Exon_19|exon 19]] [[#Biomarkers_Structural Variant|deletion]] or [[Biomarkers#L858R|exon 21 (L858R) substitution]] mutations as detected by an FDA-approved test.<ref name="insert"></ref>
-*10/18/2016: [http://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm525739.htm Label revised] to limit use to those patients whose tumors have EGFR exon 19 deletions or exon 21 L858R substitution mutations as detected by an FDA-approved test. This limitation pertains to patients with [[Non-small cell lung cancer |NSCLC]] receiving maintenance or second or greater line treatment.
+*10/18/2016: [http://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm525739.htm Label revised] to limit use to those patients whose tumors have [[Biomarkers#EGFR|EGFR]] [[Biomarkers#Exon_19|exon 19]] [[#Biomarkers_Structural Variant|deletions]] or [[Biomarkers#L858R|exon 21 L858R substitution]] mutations as detected by an FDA-approved test. This limitation pertains to patients with [[Non-small cell lung cancer |NSCLC]] receiving maintenance or second or greater line treatment.
 ==Also known as==