Systematic Review of PD-1/PD-L1 Inhibitors in Oncology: From Personalized Medicine to Public Health

Background. To review and summarize all U.S. Food and Drug Administration (FDA) approvals of programmed death (PD)1 and PD-ligand 1 blocking antibodies (collectively referred to as PD[L]1 inhibitors) over a 6-year period and corresponding companion/complementary diagnostic assays.

Materials and Methods. To determine the indications and pivotal trials eligible for inclusion, approval letters and package inserts available on Drugs@FDA were evaluated for approved PD[L]1 inhibitors to identify all new indications granted from the first approval of a PD[L]1 inhibitor on September 4, 2014, through September 3, 2020. The corresponding FDA drug and device reviews from the marketing applications for the approved indications were identified through FDA internal records. Two reviewers independently extracted information …