Analysis of Drug Development Paradigms for Immune Checkpoint Inhibitors.

ABSTRACT: Immune checkpoint inhibitors have unique toxicities and response kinetics compared with cytotoxic and gene-targeted anticancer agents. We investigated the impact of innovative/accelerated immunotherapy drug development/approval models on the accuracy of safety and efficacy assessments by searching the FDA website. Initial phase I trials for each agent were reviewed and safety and efficacy data compared with that found in later trials leading to regulatory approvals of the same agents. As of June 2017, the FDA approved six checkpoint inhibitors for a variety of cancer types. All checkpoint inhibitors received a priority review status and access to at least two additional FDA special access programs, more often breakthrough therapy designation and accelerated approval. Median clinical develo

SUBMITTER: Jardim DL 

PROVIDER: S-EPMC5899646 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature