Pfizer's Innovative Lung Cancer Targeted Therapy Dacomitinib (Vizimpro®) Officially Launched in China

XI'AN, July 6, 2019 /PRNewswire/ -- The "First Pfizer Precision Forum on Lung Cancer" was grandly held in Xi'an today. Pfizer announced the second-generation EGFR-tyrosine kinase inhibitor (TKI) targeted drug – dacomitinib (brand name: Vizimpro^®) officially launched in China, while simultaneously initiating the “EAR Lung Cancer Precision Academy” to bring new precision treatment options for lung cancer patients.

On May 15 this year, dacomitinib tablets were approved by the National Medical Products Administration (NMPA) of China for use as monotherapy in 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.^[1]. In September 2018, the U.S. Food and Drug Administration (FDA) granted priority review status to dacomitinib for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations. Currently, dacomitinib has been approved in the United States, the European Union, Japan, Canada, and other regions for first-line treatment of advanced lung cancer. In China, the marketing application was submitted almost simultaneously with global submissions and received regulatory approval.

Meeting Urgent Patient Needs, Benefiting Chinese Patients with "Innovative Precision"

To ensure that patients with advanced lung cancer across China benefit as soon as possible, Pfizer accelerated the market launch of dacomitinib in China. By early July, dacomitinib had been simultaneously launched in 33 cities nationwide, including Beijing, Shanghai, Guangzhou, and Chengdu, just one month after its approval in China. Pfizer will actively cooperate with various government initiatives to improve drug accessibility and affordability through multiple channels, and looks forward to the early inclusion of dacomitinib in the National Reimbursement Drug List to benefit more patients.

Mr. Wu Kun, General Manager of Pfizer Biopharmaceuticals Group China, stated, “Pfizer is committed to delivering breakthrough innovations that transform patients’ lives. There are still unmet needs in the field of lung cancer treatment in China; patients are eagerly awaiting new therapies, and we continue to introduce innovative medicines into China, enabling patients to access these advancements more rapidly and in sync with global developments. The nearly simultaneous approval and launch of dacomitinib in China and globally were made possible by the enrollment of hundreds of Chinese patients in its clinical trials, as well as the valuable contributions of Chinese researchers, including Professor Wu Yilong, Lifetime Director of Guangdong Provincial People’s Hospital. Looking ahead, Pfizer aims to help elevate the internationalization of clinical research in China, thereby continuously advancing the synchronized launch of innovative drugs in China and worldwide. Our goal is to respond more swiftly to the urgent survival hopes of every Chinese patient, meet their treatment needs, and improve their health.”

The Severe Landscape of Lung Cancer Has Spurred the Emergence of Innovative Targeted Therapies

Lung Cancer Ranks First in Both Incidence and Mortality Among All Cancers in China^[2]. Among them, NSCLC accounts for approximately 85% of all lung cancer cases.^[3]. In Chinese patients with NSCLC, EGFR is the most common mutation type, and approximately 50% of patients with advanced-stage disease harbor EGFR mutations.^[4],[5]. As tumor research has deepened, it has been discovered that abnormalities in the human epidermal growth factor receptor (HER) family, including EGFR, are associated with the occurrence and development of several common tumors, such as lung cancer. EGFR-TKI targeted drugs can inhibit tumor growth by suppressing the HER signal transduction pathway.

Professor Liao Meilin, Chief Expert at the Shanghai Clinical Medical Center for Lung Tumors, stated that lung cancer is a paradigm of precision therapy. Selecting appropriate targeted therapies based on patients’ genetic mutation profiles has significantly improved the efficacy of lung cancer treatment. The official launch of dacomitinib in China provides more treatment options for patients with EGFR-mutated non-small cell lung cancer (NSCLC) and those with advanced-stage disease.。

^[1]Duzexin® (Dacomitinib Tablets) Package Insert.
^[2] Bray F, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwidefor 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424.
^[3] Herbst RS, et al. The biology and management of non-small cell lung cancer. Nature. 2018;553(7689):446-454.
^[4] Yang P, et al. Clinical features of 5,628 primary lung cancer patients: experience at Mayo Clinic from 1997 to 2003. Chest. 2005;128(1):452–462.
^[5] Castellanos E, et al. Driven by Mutations: The Predictive Value of Mutation Subtype in EGFR-Mutated Non-Small Cell Lung Cancer. J Thorac Oncol. 2017;12(4):612-623.