The Impact of Survival Benefit and Study Design on FDA Approval for Anticancer Drugs Over the Past Decades.

ABSTRACT: Despite the tremendous effort in the oncology community, the success rate of anticancer development remained low at 30% to 40% from the Phase 3 study to the regulatory approval. The factors associated with the regulatory approval for market authorization have gained interest in the community to improve the success rate of drug development. Using the data from 208 Phase 3 studies for anticancer drugs, we explored the possible factors associated with the US Food and Drug Administration's (FDA's) approval by multivariate logistic regression analysis. The model incorporated 21 factors from therapeutic context, study design, and outcomes. The hazard ratio (HR) for overall survival (OS) showed a significant association with FDA approval (coefficient: -29.907, P < .001), and the age of control dr

SUBMITTER: Ishizuka K 

PROVIDER: S-EPMC12034908 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature