Dacomitinib took a step towards becoming a new treatment option in locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) on Wednesday.
The US Food and Drug Administration (FDA) accepted drug giant Pfizer’s (NYSE: PFE) New Drug Application and granted priority review for dacomitinib in this indication, with the European Medicines Agency accepting the Marketing Authorization Application in the same setting.
These submissions are based on results from the Phase III ARCHER 1050 study, a global head-to-head trial investigating dacomitinib compared to gefitinib, that showed the Pfizer candidate may offer a clinically meaningful improvement over the comparator, which is sold by AstraZeneca (LSE: AZN) under the brand name Iressa.
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