Cite this page: Kwee HG. Afatinib. PathologyOutlines.com website. http://www.pathologyoutlines.com/topic/drugsafatinib.html. Accessed May 26th, 2019.
- 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