Pfizer announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted priority review for dacomitinib. The European Medicines Agency has also accepted the Marketing Authorization Application for dacomitinib for the same indication.
The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists.
Dacomitinib is a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations.The drug has not received regulatory approval in any country. Dacomitinib is the second investigational Pfizer lung cancer medicine to receive regulatory acceptance within two months, reinforcing Pfizer’s commitment to patients with NSCLC where there continues to be a significant unmet need.