Pfizer Announces China Approval of Lung Cancer Innovative Drug Vizimpro® (Dacomitinib) for First-Line Treatment of EGFR-Mutated NSCLC

Pfizer Announces Approval of Dacomitinib (Vizimpro®) in China for First-Line Treatment of EGFR-Mutated NSCLCPfizer announced today that Vizimpro® (dacomitinib tablets), an innovative targeted therapy for lung cancer, was approved by the National Medical Products Administration (NMPA) of China on May 15. It is indicated as a monotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. Global registration studies demonstrated that Vizimpro® significantly improved progression-free survival (PFS) and extended overall survival (OS) compared to standard targeted therapies. The median OS achieved was 34.1 months, making it the first EGFR tyrosine kinase inhibitor (EGFR-TKI) to provide a clinically meaningful improvement in OS for patients with EGFR-mutated NSCLC. This approval marks the first time in China that a drug has been submitted for regulatory review and approved in near synchrony with global markets, including the United States, Europe, and Japan.

The 2018 Global Cancer Statistics Report indicates that lung cancer ranks first in both incidence and mortality among all types of cancer in China, making it the leading malignant tumor. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases. Among Chinese patients with NSCLC, EGFR mutations are the most common type, with an incidence rate of nearly 50%.

The approval of Dacomitinib® is based on the international, multicenter, Phase III, open-label clinical study ARCHER 1050, led by Professor Wu Yilong, Lifetime Professor at Guangdong Provincial People's Hospital, and Professor Tony Mok, Director of the Department of Clinical Oncology at The Chinese University of Hong Kong Faculty of Medicine. The study aimed to evaluate the efficacy and safety of dacomitinib (a second-generation EGFR TKI) versus gefitinib (a first-generation EGFR TKI). A total of 452 patients were randomized in this study, including 231 Chinese patients.

In 2018, the U.S. FDA granted Priority Review status to Tagrisso® for the first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR mutations. The FDA grants priority review to drugs that may represent significant advances in treatment or where no adequate treatment exists. Currently, Tagrisso® has been approved for first-line treatment in the United States, the European Union, Japan, Canada, and other regions.