Pfizer announces innovation target drug Dozerun ® (Dacotinib) approved by China's National Drug Administration

recently, Pfizer(http://announced that the innovative target ofdrug(http://Dozerun ® (Dacostinib) on May 15 was approved by the State administration ofMedicines
and http://Regulatory Authority of ChinaThe drug is used in the first-line treatment of patients with late localized or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) 19 epidermis missing mutation or no21 exon L858R displacement mutationglobally registered study showed that Dozerun's ® significantly improved progression less than standard targeted drug therapy and extended total survival (OS), with a median OS of 34.1 months, making it the first EGFR-TKI to provide clinically significant OS improvement for patients with EGFR mutation NSCLCthe approval in China for the first time to achieve almost the United States, Europe, Japan and other countries in the global simultaneous submission and regulatory approvalThe approval of the Dozerun ® is based on the international multi-center, Phase III, open-label clinical research ARCHER1050, led by Professor Wu Yilong, tenured professor of Guangdong Provincial People's Hospital, professor tony Mok, head of the Clinical Oncology Department of the Faculty of Medicine of the Chinese University of Hong Kong, to assess the efficacy and safety of the treatment of Dacostinib (second generation EGFR TKI) or Giffitinib (generation EGFR TKI)The study randomly grouped 452 patients, including 231 Chinese patientsIn 2018, the U.SFDA (http:// granted Dozerun ® priority review eligibility for patients with localized advanced or metastatic EGFR mutations The FDA will give priority approval in the event of significant progress in treatment or without appropriate treatment stodgy drugs at present, Dozerun ® in the United States, the European Union, Japan, Canada and other approved for first-line treatment