Posted by Michael Wonder on 04 Apr 2018
U.S. FDA and European Medicines Agency accept regulatory submissions for review of dacomitinib to treat metastatic non-small-cell lung cancer with EGFR-activating mutations
4 April 2018 - FDA priority review granted for U.S. new drug application.
Pfizer today announced that the U.S. 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 with EGFR-activating mutations. The EMA has also accepted the marketing authorisation 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. The Prescription Drug User Fee Act goal date for a decision by the FDA is in September 2018.
