Comparative Assessment of Pivotal Trials Supporting the Indication Approvals of Innovative and Modified New Anticancer Drugs in China, 2016-2022.

ABSTRACT: Background: Since the launch of drug regulatory reform in 2015, China has substantially increased the availability of new cancer therapies. However, the efficacy evidence criteria for modified new anticancer drugs have not been evaluated. This cross-sectional study aimed to assess the pivotal trials supporting the indication approvals of innovative and modified new chemical anticancer drugs in China. Methods: The characteristics of indications, regulatory aspects, and pivotal trial designs were extracted and described. The primary efficacy endpoints of the pivotal clinical trials, including overall survival (OS) and progression-free survival (PFS), were quantitatively assessed by meta-analysis. Results: Between 2016 and 2022, 77 cancer therapeutics for 107 indications

SUBMITTER: Fu L 

PROVIDER: S-EPMC12046133 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature