In July 2013, afatinib was approved by the US Food and Drug Administration for first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Quiagen’s therascreen EGFR RGQ PCR Kit for detection of EGFR exon 19 deletions (del19) and exon 21 (L858R) substitution mutations was concurrently approved. Afatinib is an oral selective ErbB family inhibitor that irreversibly blocks signaling from EGFR/ErbB1, HER2/ErbB2, and ErbB4 and has shown broad-spectrum activity against tumor cells with EGFR mutations.
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