biostudies-literatureZhou MChinese National Major Project for New Drug Innovation36https://www.ebi.ac.uk/biostudies/studies/S-EPMC6585030biostudies-literatureUnknown39(1)<h4>Background</h4>On May 8, 2018, the China National Medical Products Administration (NMPA) approved anlotinib, an orally administered anti-angiogenesis inhibitor, for the treatment of patients with advanced non-small cell lung cancer (NSCLC) who have progressed after treatment with two or more lines of prior systemic chemotherapy. China NMPA reviewed and inspected a regional double-blinded, placebo-controlled, Phase III trial comparing the overall survival (OS) of NSCLC patients between the anlotinib and placebo arms. A total of 437 patients were randomized (2:1) to receive either anlotinib (n = 294) or placebo (n = 143) once daily on a 2-week on and 1-week off schedule. Patients with epidermal growth factor receptor (EGFR) or activating anaplastic lymphoma kinase (ALK) genomic tumor abeCancer communications (London, England)China National Medical Products Administration approval summary: anlotinib for the treatment of advanced non-small cell lung cancer after two lines of chemotherapy.PMC65850302017ZX09304015Zhou MZou LZhang HTong XHao RZhao XChen DShi YGao RPan JLiu ZYang ZTang LXia LQi YChen XSong YfalseChina National Medical Products Administration approval summary: anlotinib for the treatment of advanced non-small cell lung cancer after two lines of chemotherapy.<h4>Background</h4>On May 8, 2018, the China National Medical Products Administration (NMPA) approved anlotinib, an orally administered anti-angiogenesis inhibitor, for the treatment of patients with advanced non-small cell lung cancer (NSCLC) who have progressed after treatment with two or more lines of prior systemic chemotherapy. China NMPA reviewed and inspected a regional double-blinded, placebo-controlled, Phase III trial comparing the overall survival (OS) of NSCLC patients between the anlotinib and placebo arms. A total of 437 patients were randomized (2:1) to receive either anlotinib (n = 294) or placebo (n = 143) once daily on a 2-week on and 1-week off schedule. Patients with epidermal growth factor receptor (EGFR) or activating anaplastic lymphoma kinase (ALK) genomic tumor abe2019-01-01T00:00:00Z2019 Jun2025-04-04T22:51:42.495Z2019-07-24T07:23:52ZS-EPMC65850303122122110.1186/s40880-019-0383-7