Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates
In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies deliver cytotoxic small-molecule drug payloads to cancer cells. The cytotoxic payload attaches to a monoclonal antibody (designed for binding to the target) through a linker. Having a solid clinical pharmacology strategy is essential to successfully developing these therapies. The US … Continued