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.
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Diseases for which it is used
Patient drug information
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.
- 4/15/2016: Approved for treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy.
- 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.
Also known as
- Code names: BIBW 2992, BIBW-2992
- Generic name: afatinib dimaleate
- Brand names: Afanix, Gilotrif, Giotrif, Tomtovok, Tovok, Xovoltib