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FDA Approves Dacomitinib for Frontline EGFR+ NSCLC

Jason M. Broderick @jasoncology
Published: Friday, Sep 28, 2018

Tony Mok, MD

Tony Mok, MD

The FDA has approved dacomitinib (Vizimpro) for the frontline treatment of patients with metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 L858R substitution mutations, according to Pfizer, the manufacturer of the pan-human EGFR tyrosine kinase inhibitor (TKI).

The approval is based on 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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Community Practice Connections™: 2nd Annual School of Nursing Oncology™Sep 28, 20191.5
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