Difference between revisions of "Afatinib (Gilotrif)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *7/12/2013: [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]] [[# | + | *7/12/2013: [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 LUX-Lung 3])'' |
*4/15/2016: 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 LUX-Lung 8])'' | *4/15/2016: 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 LUX-Lung 8])'' | ||
*1/12/2018: 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 LUX-Lung 2], [https://clinicaltrials.gov/ct2/show/NCT00949650 LUX-Lung 3], and [https://clinicaltrials.gov/ct2/show/NCT01121393 LUX-Lung 6])'' | *1/12/2018: 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 LUX-Lung 2], [https://clinicaltrials.gov/ct2/show/NCT00949650 LUX-Lung 3], and [https://clinicaltrials.gov/ct2/show/NCT01121393 LUX-Lung 6])'' | ||
Revision as of 20:39, 11 May 2021
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
- Afatinib (Gilotrif) package insert[1]
- Afatinib (Gilotrif) patient drug information (Chemocare)[4]
- Afatinib (Gilotrif) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 7/12/2013: Approved for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor exon 19 deletion or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. (Based on LUX-Lung 3)
- 4/15/2016: Approved for treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy. (Based on LUX-Lung 8)
- 1/12/2018: Approval expanded for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test. (Based on LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6)
Also known as
- Code names: BIBW 2992, BIBW-2992
- Generic name: afatinib dimaleate
- Brand names: Afanix, Gilotrif, Giotrif, Tomtovok, Tovok, Xovoltib