The company is seeking approval of the drug as a first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations.

The submissions are based on data from the Phase III ARCHER 1050 study, a global head-to-head trial which showed that dacomitinib may offer a clinically meaningful improvement over gefitinib.

Patients receiving dacomitinib in the study experienced a median progression-free survival (PFS) of 14.7 months compared with 9.2 months in patients treated with gefitinib, representing a 41 percent reduction in the risk of disease progression or death.

On the safety side, the firm noted that adverse events (AEs) observed with dacomitinib in the study were consistent with findings from previous trials, with the most common AEs found to be diarrhea (87 percent), nail changes (62 percent), rash/dermatitis acneiform (49 percent), and mouth sores (44 percent).

"While significant progress has been made in the treatment of patients with non-small cell lung cancers harboring EGFR-activating mutations, it remains a challenging disease and new treatment options are needed," said Mace Rothenberg, chief development officer, Oncology, Pfizer Global Product Development.

"These filing acceptances are an important step toward increasing treatment options for patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer."

US regulators have granted the submission a priority review.

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