Perspectives and Insights on Biomarker-Driven Breast Cancer Therapeutics: From Preclinical Development to Submission of an Investigational New Drug (IND) Application to the FDA

Biomarker-driven breast cancer therapies target molecular abnormalities associated with tumor growth and treatment resistance. Human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugates (ADCs) and estrogen receptor 1 (ESR1)-directed selective estrogen receptor degraders (SERDs) represent important advances in precision oncology. These therapies address distinct biological mechanisms and require different approaches to drug development (Najjar et al., 2022; U.S. Food and Drug Administration [FDA], 2023). Evaluating their pharmacology, pharmacokinetics, toxicity, chemical properties, formulation, and stability is essential before human exposure. This article examines these considerations and emerging technologies that inform the preclinical development of investigational breast cancer therapeutics.