FDA and EMA Accept Regulatory Submissions for Dacomitinib in Metastatic NSCLC With EGFR-Activating Mutations

April 9, 2018 – On April 4, Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) accepted the company’s new drug application and granted Priority Review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for the first-line treatment of patients with locally advanced or metastatic non­–small cell lung cancer (NSCLC) with EGFR-activating mutations. The European Medicines Agency (EMA) has also accepted … (leggi tutto)