Difference between revisions of "Afatinib (Gilotrif)"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m (Text replacement - "(Gliotrif)" to "(Gilotrif)")
m
(35 intermediate revisions by 4 users not shown)
Line 1: Line 1:
 
==General information==
 
==General information==
−
Class/mechanism: Irreversible tyrosine kinase inhibitor of EGFR (epidermal growth factor receptor, ErbB1), HER2 (human epidermal growth factor receptor 2, ErbB2), and HER4 (human epidermal growth factor receptor 4, ErbB4). Inhibition of tyrosine kinase autophosphorylation inhibits ErbB signaling.<ref name=insert>[http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Gilotrif/Gilotrif.pdf Afatinib (Gilotrif) package insert]</ref><ref>[[Media:Afatinib.pdf | Afatinib (Gilotrif) package insert (locally hosted backup)]]</ref><ref>[http://www.gilotrif.com/ Gliotrif manufacturer's website]</ref>
+
Class/mechanism: Irreversible tyrosine kinase inhibitor of EGFR (epidermal growth factor receptor, ErbB1), HER2 (human epidermal growth factor receptor 2, ErbB2), and HER4 (human epidermal growth factor receptor 4, ErbB4). Inhibition of tyrosine kinase autophosphorylation inhibits ErbB signaling.<ref name=insert>[http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Gilotrif/Gilotrif.pdf Afatinib (Gilotrif) package insert]</ref><ref>[[:File:Afatinib.pdf | Afatinib (Gilotrif) package insert (locally hosted backup)]]</ref><ref>[http://www.gilotrif.com/ Gliotrif manufacturer's website]</ref>
  
 
Route: PO  
 
Route: PO  
 
<br>Extravasation: n/a
 
<br>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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
+
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://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==
 
*[[Head and neck cancer]]
 
*[[Head and neck cancer]]
−
*[[Non-small cell lung cancer]]
+
*[[Non-small_cell_lung_cancer,_EGFR-mutated|EGFRm NSCLC]]
 +
*[[Non-small cell lung cancer, squamous|Squamous NSCLC]]
  
 
==Patient drug information==
 
==Patient drug information==
 
*[http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Gilotrif/Gilotrif.pdf Afatinib (Gilotrif) package insert]<ref name="insert"></ref>
 
*[http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Gilotrif/Gilotrif.pdf Afatinib (Gilotrif) package insert]<ref name="insert"></ref>
−
*[http://chemocare.com/chemotherapy/drug-info/afatinib.aspx Afatinib (Gilotrif) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/afatinib.aspx Afatinib (Gilotrif) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/afatinib.aspx Afatinib (Gilotrif) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/afatinib.aspx Afatinib (Gilotrif) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/afatinib-patient-drug-information Afatinib (Gilotrif) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/afatinib-patient-drug-information Afatinib (Gilotrif) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/afatinib-patient-drug-information Afatinib (Gilotrif) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/afatinib-patient-drug-information Afatinib (Gilotrif) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
*7/12/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm360574.htm FDA approved] for "the 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."
+
*2013-07-12: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm360574.htm Approved] for the [[Contexts#First-line_therapy|first-line treatment]] of patients with [[Contexts#Metastatic|metastatic]] [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] whose tumors have [[Biomarkers#EGFR|epidermal growth factor receptor]] [[Biomarkers#Exon_19|exon 19]] [[Biomarkers#Deletion|deletion]] or [[Biomarkers#L858R|exon 21 (L858R) substitution]] mutations as detected by an FDA-approved test. ''(Based on LUX-Lung 3)''
 +
*2016-04-15: Approved for treatment of patients with [[Contexts#Metastatic|metastatic]], [[Non-small cell lung cancer, squamous|squamous NSCLC]] [[Contexts#Subsequent-line_therapy|progressing after]] [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(Based on LUX-Lung 8)''
 +
*2018-01-12: Approval expanded for a broadened indication in [[Contexts#First-line_therapy|first-line treatment]] of patients with [[Contexts#Metastatic|metastatic]] [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] whose tumors have [[Biomarkers#Non-resistant|non-resistant]] [[Biomarkers#EGFR|epidermal growth factor receptor]] mutations as detected by an FDA-approved test. ''(Based on LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6)''
  
 +
==History of changes in EMA indication==
 +
*2013-09-25: Initial marketing authorization as Giotrif as monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] with activating EGFR mutation(s).
 +
*2016-03-31: Extension of indications to include patients with locally advanced or metastatic [[Non-small cell lung cancer, squamous|Non-small cell lung cancer (NSCLC) of squamous histology]] progressing on or after platinum-based chemotherapy.
 +
==History of changes in Health Canada indication==
 +
*2013-11-01: Initial notice of compliance as monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor-naïve patients with metastatic (including cytologically proven pleural effusion) [[Non-small cell lung cancer, nonsquamous|adenocarcinoma of the lung]] with activating EGFR mutation(s).
 +
*2016-08-25: New indication for second line treatment of patients with locally advanced or metastatic [[Non-small cell lung cancer, squamous|non-small cell lung cancer (NSCLC) of squamous histology]].
 +
*2018-09-20: Updated indication (unclear)
 +
==History of changes in PMDA indication==
 +
*2014-01-17: Initial approval for the treatment of unresectable advanced or recurrent [[non-small cell lung cancer]] with EGFR gene mutation.
 
==Also known as==
 
==Also known as==
−
*'''Code names:''' BIBW 2992, BIBW-2992
+
*'''Code names:''' BIBW-2992
 +
*'''Generic name:''' afatinib dimaleate
 
*'''Brand names:''' Afanix, Gilotrif, Giotrif, Tomtovok, Tovok, Xovoltib
 
*'''Brand names:''' Afanix, Gilotrif, Giotrif, Tomtovok, Tovok, Xovoltib
  
Line 26: Line 39:
 
<references/>
 
<references/>
  
−
[[Category:Drug index]]
+
[[Category:Drugs]]
 
[[Category:Oral medications]]
 
[[Category:Oral medications]]
 
[[Category:Mutation-specific medications]]
 
[[Category:Mutation-specific medications]]
  
−
[[Category:Kinase inhibitors]]
 
 
[[Category:EGFR inhibitors]]
 
[[Category:EGFR inhibitors]]
 
[[Category:ERBB2 inhibitors]]
 
[[Category:ERBB2 inhibitors]]
Line 37: Line 49:
 
[[Category:Head and neck cancer medications]]
 
[[Category:Head and neck cancer medications]]
 
[[Category:Non-small cell lung cancer medications]]
 
[[Category:Non-small cell lung cancer medications]]
−
[[Category:Drugs FDA approved in 2013]]
+
[[Category:Non-small cell lung cancer, squamous medications]]
 +
 
 +
[[Category:EMA approved in 2013]]
 +
[[Category:FDA approved in 2013]]
 +
[[Category:Health Canada approved in 2013]]
 +
[[Category:PMDA approved in 2014]]
 +
[[Category:WHO Essential Cancer Medicine]]

Revision as of 00:28, 9 September 2023

General information

Class/mechanism: Irreversible tyrosine kinase inhibitor of EGFR (epidermal growth factor receptor, ErbB1), HER2 (human epidermal growth factor receptor 2, ErbB2), and HER4 (human epidermal growth factor receptor 4, ErbB4). Inhibition of tyrosine kinase autophosphorylation inhibits ErbB signaling.[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

History of changes in EMA indication

  • 2013-09-25: Initial marketing authorization as Giotrif as monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s).
  • 2016-03-31: Extension of indications to include patients with locally advanced or metastatic Non-small cell lung cancer (NSCLC) of squamous histology progressing on or after platinum-based chemotherapy.

History of changes in Health Canada indication

  • 2013-11-01: Initial notice of compliance as monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor-naïve patients with metastatic (including cytologically proven pleural effusion) adenocarcinoma of the lung with activating EGFR mutation(s).
  • 2016-08-25: New indication for second line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) of squamous histology.
  • 2018-09-20: Updated indication (unclear)

History of changes in PMDA indication

  • 2014-01-17: Initial approval for the treatment of unresectable advanced or recurrent non-small cell lung cancer with EGFR gene mutation.

Also known as

  • Code names: BIBW-2992
  • Generic name: afatinib dimaleate
  • Brand names: Afanix, Gilotrif, Giotrif, Tomtovok, Tovok, Xovoltib

References

  1. ↑ 1.0 1.1 1.2 Afatinib (Gilotrif) package insert
  2. ↑ Afatinib (Gilotrif) package insert (locally hosted backup)
  3. ↑ Gliotrif manufacturer's website
  4. ↑ Afatinib (Gilotrif) patient drug information (Chemocare)
  5. ↑ Afatinib (Gilotrif) patient drug information (UpToDate)
Retrieved from "https://hemonc.org/w/index.php?title=Afatinib_(Gilotrif)&oldid=77562"