FDA accepted the regulatory submissions for review of a new second-generation EGFR inhibitor in first-line NSCLC

2018-05-02

Dacomitinib is a new second-generation EGFR tyrosine kinase inhibitor that can irreversibly inhibit all kinase activity of the ErbB family (EGFR/HER1, HER2, and HER4). In a randomized phase III trial (ARCHER 1050), patients with EGFR-mutated (exon 19 deletion or L858R mutation) NSCLC were treated with dacomitinib (n=227) or gefitinib (n=225). The median progression-free survival was 14.7 months in the dacomitinib group and 9.2 months in the gefitinib group. The discontinuation rate due to adverse events related to study drug was 10% in dacomitinib group, compared to 7% for gefitinib group. The positive results revealed that dacomitinib could be a new treatment option for patients with EGFR-mutated NSCLC. Based on these results, the FDA accepted the regulatory submissions for review of dacomitinib for first-line treatment of patients with NSCLC.

Wu YL, et al. Lancet Oncol. 18(11):1454-1466 (2017)

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