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Dacomitinib Approved in Europe for Frontline EGFR+ NSCLC

Jason M. Broderick @jasoncology
Published: Wednesday, Apr 03, 2019

Federico Cappuzzo, MD

Federico Cappuzzo, MD

The European Commission has approved dacomitinib (Vizimpro) for the frontline treatment of adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR-activating mutations, according to Pfizer, the manufacturer of the pan-human EGFR TKI.

The approval was based on findings from the phase III ARCHER 1050 trial, in which dacomitinib reduced the risk of disease progression or death by more than 40% and resulted in an average 6.5-month improvement in response duration compared with gefitinib (Iressa) as a first-line treatment for patients with advanced, EGFR-positive NSCLC.

The median progression-free survival (PFS) for patients who received dacomitinib was 14.7 months compared with 9.2 months for participants who received gefitinib (HR, 0.59; 95% CI, 0.47-0.74; P <.0001). The median duration of response (DOR) was 14.8 months with dacomitinib versus 8.3 months with gefitinib (HR, 0.40; 95% CI, 0.31-0.53; P <.0001).1

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