Drugs of interest to pathologists
Drugs related to surgical pathology

Topic Completed: 1 February 2014

Minor changes: 22 August 2019

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PubMed Search: Afatinib [title] review[ptyp]

Him G. Kwee, M.D.
Page views in 2019: 83
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Cite this page: Kwee HG. Afatinib. PathologyOutlines.com website. http://www.pathologyoutlines.com/topic/drugsafatinib.html. Accessed August 12th, 2020.
Definition / general
  • Afatinib is an irreversible EGFR / HER2 / HER4 inhibitor
Trade name
  • Gilotrif®
Clinical information
  • Approved by the U.S. Food and Drug Administration in July 2013 for treatment of metastatic non small cell lung carcinoma with the most common mutations in the EGFR gene, namely exon 19 deletions and exon 21 L858R substitution mutations
  • Acts as an angiokinase inhibitor (Wikipedia: Afatinib [Accessed 14 December 2018])
  • The drug's labeling requires the use of an FDA approved test to select EGFR mutation positive patients for the therapy
  • FDA has approved a companion diagnostic test to guide the use of this drug, namely therascreen EGFR RGQ PCR (Qiagen)
  • Analytical performance of the test has been established for 21 EGFR mutations including the most prevalent resistance mutation, T790M
  • Cost for this oral drug: $5,500 per month
  • Side effects include diarrhea, skin bullous eruption or exfoliation, oral lesions, interstitial lung disease, liver test abnormalities, keratitis, fetal malformations
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