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FDA Grants Dacomitinib Priority Review for Frontline EGFR+ NSCLC

Jason M. Broderick @jasoncology
Published: Wednesday, Apr 04, 2018

Dr. Mace Rothenberg

Mace Rothenberg, MD
The FDA has granted a priority review designation to dacomitinib for the frontline treatment of patients with EGFR-positive locally advanced or metastatic non–small cell lung cancer (NSCLC), according to Pfizer, the manufacturer of the pan-human EGFR tyrosine kinase inhibitor (TKI).

The most frequent grade 3 AEs in the dacomitinib arm were rash (14%) and diarrhea (8%). Two percent of patients receiving dacomitinib had grade 4 AEs. There were two grade 5 AEs, diarrhea and liver disease. Discontinuation due to treatment-related AEs occurred in 10% versus 7% of the dacomitinib versus gefitinib arms, respectively.
Mok T, Cheng Y, Zhou X, et al. Dacomitinib versus gefitinib for the first-line treatment of advanced EGFR mutation positive non-small cell lung cancer (ARCHER 1050): a randomized, open-label phase 3 trial. J Clin Oncol. 2017;35(suppl; abstr LBA9007).

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