Gefitinib, an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase (TK), was licensed by the EMA for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR TK in June 2009.
Overall, four studies were found reporting results for patients with EGFR mutations. Even though overall survival was not prolonged, these trials showed consistently improved results for progression-free survival and quality-of-life outcomes. Also, adverse events occurred less frequently than in patients treated with standard platinum-based chemotherapy. Gefitinib has thus been incorporated into several guidelines and has increasingly become standard 1st -line therapy for patients with EGFR mutations.
Of interest will be the comparison to erlotinib, another TKI, for which EMA’s Committee for Medicinal Products for Human Use has recently adopted a positive opinion also for the1st-line setting and for NSCLC patients with activating mutations of EGFR.