On July 12, the FDA announced that it had approved the targeted therapy afatinib (Gilotrif) for the treatment of metastatic non-small cell lung cancer (NSCLC) with mutations in the epidermal growth factor receptor (EGFR) gene.
EGFR mutations occur in about 10 to 15 percent of all NSCLC patients. The overexpression of the EGFR protein caused by the mutation leads to rapid cell division in tumors. Prior to the approval of afatinib, patients in the United States could only take erlotinib (Tarceva) to combat the EGFR mutation. The third major drug available to treat EGFR-mutated tumors, gefitinib (Iressa) has not yet been approved by the United States but is readily available in many other countries. Erlotinib has consistently outperformed gefitinib, so its lack of availability in the U.S. is no huge loss. Continue reading…
Food and Drug Administration (FDA) | July 12, 2013
Based on the positive results of a recent clinical trial, the FDA approved afatinib for first-line treatment of patients with late-stage, non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. The drug, which will be marketed under the name Gilotrif, is specifically intended for patients with two particular EGFR mutations: exon 19 deletion and exon 21 L858R substitution. The FDA also approved the therascreen EGFR RGQ PCR Kit, a companion diagnostic used to test for EGFR mutations. Afatinib differs from other EGFR inhibitors like erlotinib (Tarceva) and gefitinib (Iressa) in that it irreversibly destroys the EGFR protein, instead of just reversibly blocking it, and also inhibits several other related proteins.