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# Pfizer NDA for Lung Cancer Drug Given Priority Review
- URL: https://www.fdaweb.com/pfizer-nda-for-lung-cancer-drug-given-priority-review/
- Published: 2018-04-04T12:00:00.000Z
- Updated: 2026-09-14T23:57:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141142

FDA has accepted for priority review a Pfizer NDA for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR-activating mutations. The European Medicines Agency has also accepted an application for dacomitinib for the same indication.

The submission is supported by data from the Phase 3 ARCHER 1050 study, a global head-to-head trial investigating dacomitinib compared to AstraZeneca’s Iressa (gefitinib), which showed that dacomitinib may offer a clinically meaningful improvement over gefitinib. Patients treated with dacomitinib in the study experienced a median progression-free survival of 14.7 months compared with 9.2 months in patients treated with gefitinib, the company says.