Difference between revisions of "Afatinib (Gilotrif)"

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==History of changes in FDA indication==
 
==History of changes in FDA indication==
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*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])''
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*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/NCT00949650 Clinical Trial Registry] LUX-Lung 3])''
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*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])''
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*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/NCT01523587 Clinical Trial Registry] LUX-Lung 8])''
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*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])''
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*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/NCT00525148 Clinical Trial Registry] LUX-Lung 2], [https://clinicaltrials.gov/ct2/show/NCT00949650 Clinical Trial Registry] LUX-Lung 3], and [https://clinicaltrials.gov/ct2/show/NCT01121393 Clinical Trial Registry] LUX-Lung 6])''
  
 
==History of changes in EMA indication==
 
==History of changes in EMA indication==

Revision as of 19:45, 2 June 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

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)

Also known as

  • Code names: BIBW 2992, 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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