Pfizer Korea said Thursday that the Ministry of Food and Drug Safety has approved Vizimpro (ingredient: Dacomitinib) as the first-line treatment for mutated lung cancer patients.

Patients with non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR)-mutated exon 19 or 21 deletions (19del and 21del) will be treated with Vizimpro in the initial stage.

The result of the comparison between the first-generation EGFR-tyrosine kinase inhibitors (TKI) Gefitinib and Vizimpro-administered groups through ARCHER1050 clinical trial showed Vizimpro was better than Gefitinib.

ARCHER1050 is a multinational, multicenter, randomized, open-label phase 3 clinical trial of EGFR mutated NSCLC patients without the history of administering Dacomitinib or Gefitinib.

The median progression-free survival period in the Vizimpro group was 14.7 months, compared to 9.2 months for Gefitinib group, with a hazard ratio (HR) of 0.59, 95-percent confidence interval (CI) of 0.47 to 0.74, and two-sided probability value of lower than 0.0001.

The median overall survival period of Gefitinib was 26.8 months, but that of Vizimpro was 34.1 months with 0.760 HR, 0.582 to 0.993 95 percent CI, and 0.044 2-sided P.

"Pfizer will continue to provide more effective treatment options for Korean patients and medical options through new cancer medicine portfolios, which include Vizimpro," said Song Chan-woo, the company’s managing director and head of operation division.

Pfizer also won the sales approval from the U.S. Food and Drug Administration in 2018, and the European Union Committee, in 2019.