China National Medical Products Administration approval summary: anlotinib for the treatment of advanced non-small cell lung cancer after two lines of chemotherapy.

ABSTRACT:

Background

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

SUBMITTER: Zhou M 

PROVIDER: S-EPMC6585030 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature