{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Zhou M"],"funding":["Chinese National Major Project for New Drug Innovation"],"pagination":["36"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC6585030"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["39(1)"],"pubmed_abstract":["<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 abe"],"journal":["Cancer communications (London, England)"],"pubmed_title":["China National Medical Products Administration approval summary: anlotinib for the treatment of advanced non-small cell lung cancer after two lines of chemotherapy."],"pmcid":["PMC6585030"],"funding_grant_id":["2017ZX09304015"],"pubmed_authors":["Zhou M","Zou L","Zhang H","Tong X","Hao R","Zhao X","Chen D","Shi Y","Gao R","Pan J","Liu Z","Yang Z","Tang L","Xia L","Qi Y","Chen X","Song Y"],"additional_accession":[]},"is_claimable":false,"name":"China National Medical Products Administration approval summary: anlotinib for the treatment of advanced non-small cell lung cancer after two lines of chemotherapy.","description":"<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 abe","dates":{"release":"2019-01-01T00:00:00Z","publication":"2019 Jun","modification":"2025-04-04T22:51:42.495Z","creation":"2019-07-24T07:23:52Z"},"accession":"S-EPMC6585030","cross_references":{"pubmed":["31221221"],"doi":["10.1186/s40880-019-0383-7"]}}