Difference between revisions of "Afatinib (Gilotrif)"

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==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>
−
*[https://chemocare.com/chemotherapy/drug-info/afatinib.aspx Afatinib (Gilotrif) patient drug information (Chemocare)]<ref>[https://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==
−
*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 [https://clinicaltrials.gov/ct2/show/[https://clinicaltrials.gov/ct2/show/NCT00949650 Clinical Trial Registry] LUX-Lung 3])''
+
*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 [https://clinicaltrials.gov/ct2/show/[https://clinicaltrials.gov/ct2/show/NCT01523587 Clinical Trial Registry] LUX-Lung 8])''
+
*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 [https://clinicaltrials.gov/ct2/show/[https://clinicaltrials.gov/ct2/show/NCT00525148 Clinical Trial Registry] LUX-Lung 2], [https://clinicaltrials.gov/ct2/show/[https://clinicaltrials.gov/ct2/show/NCT00949650 Clinical Trial Registry] LUX-Lung 3], and [https://clinicaltrials.gov/ct2/show/[https://clinicaltrials.gov/ct2/show/NCT01121393 Clinical Trial Registry] LUX-Lung 6])''
+
*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==
 
==History of changes in EMA indication==
−
*2013-09-25: Initial marketing authorization as Giotrif
+
*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==
 
==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).
 
*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]].
 
*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)
 
*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
 
*'''Generic name:''' afatinib dimaleate
 
*'''Brand names:''' Afanix, Gilotrif, Giotrif, Tomtovok, Tovok, Xovoltib
 
*'''Brand names:''' Afanix, Gilotrif, Giotrif, Tomtovok, Tovok, Xovoltib
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[[Category:FDA approved in 2013]]
 
[[Category:FDA approved in 2013]]
 
[[Category:Health Canada approved in 2013]]
 
[[Category:Health Canada approved in 2013]]
 +
[[Category:PMDA approved in 2014]]
 
[[Category:WHO Essential Cancer Medicine]]
 
[[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)
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