Clinical Pharmacology Packages of FDA-Approved Biologic License Applications in Oncology from 2015 to 2025

The landscape of oncologic therapies has undergone large changes since the introduction of monoclonal antibody (mAb) based immunotherapies in the late 1990s and early 2000s. MAb-based therapeutics, also called biologics or large molecules, have distinct pharmacological characteristics compared to chemotherapeutics and small molecules. Development of biologics requires thorough assessment of pharmacokinetic (PK) and pharmacodynamic (PD) characteristics to ensure safety and demonstration of efficacy. This review provides an overview of the clinical pharmacology packages of biologics for the treatment of oncologic malignancies approved by the U.S. Food and Drug Administration (FDA) over the past decade (January 2015 and August 2025). The conduct of population PK (PopPK) and exposure-eesponse (E-R) analyses, as well as assessments for drug–drug interactions (DDIs), immunogenicity, and QT prolongation risk are discussed. The aim of this review is to provide insight into the clinical pharmacology assessments for approval of antibody-based therapies in oncology as well as provide a longitudinal view of clinical pharmacology packages in this space.