EMA recommends dacomitinib for EGFR activating mutation-positive NSCLC
medwireNews: The selective EGFR–tyrosine kinase inhibitor dacomitinib has been granted a positive opinion for first-line use in European patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR activating mutations.
The EMA’s recommendation for marketing authorization follows the 2018 US FDA approval of the agent in patients with an activating EGFR exon 19 deletion or an exon 21 L858R substitution. 16164208 MMO, 16164214 medwireNews
Dacomitinib was demonstrated to offer significantly longer progression-free survival than gefitinib for patients with treatment-naïve disease in the ARCHER 1050 trial. 15847706 MMo, 15847714 medwireNews
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