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).
“EGFR-mutated advanced non-small cell lung cancer is a common illness, especially in the Asian population, and new treatment options will ultimately benefit patients,” said Professor Tony Mok, MD, primary investigator for the ARCHER 1050 study and chair of Department of Clinical Oncology, The Chinese University of Hong Kong.
“The findings from ARCHER 1050 suggest that Vizimpro should be considered as a new first-line treatment option for patients with EGFR-mutated non-small cell lung cancer exon 19 deletion or exon 21 L858R substitution mutations.”
The drug is also under review in Europe.