USA – US green light for Pfizer’s lung cancer drug

Pfizer’s pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor dacomitinib has been approved in the US as a treatment for some forms of lung cancer.

The drug has been cleared under the brand name Vizimpro as a first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations.

The green light is based on results of the Phase III ARCHER 1050 study, a global head-to-head trial which showed that Vizimpro 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 found to be diarrhoea (87 percent), nail changes (62 percent), rash/dermatitis acneiform (49 percent), and mouth sores (44 percent)…