FDA, EMA Accept Pfizer’s Filings for Lung Cancer Drug DacomitinibBy
The US Food and Drug Administration (FDA) has accepted Pfizer’s new drug application and granted priority review for dacomitinib, 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 with EGFR-activating mutations. Separately, the European Medicines Agency has also accepted the marketing authorization application for dacomitinib for the same indication.
The Prescription Drug User Fee Act goal date for a decision by the FDA is in September 2018. The drug has not received regulatory approval in any country.
In 2012, Pfizer and SFJ Pharmaceuticals Group, a Pleasanton, California-based pharmaceutical company, formed a development agreement to conduct the Phase III trial investigating dacomitinib across multiple sites.