(150a) Regulatory Considerations for Antibody-Drug Conjugates (ADCs) (invited talk)

Antibody-drug conjugates (ADCs) are amongst the fastest growing drug classes in oncology, and their use could expand to other therapeutic areas in the future. ADCs are highly complicated molecules, that include a combination of a monoclonal antibody, a cleavable or non-cleavable linker, and a drug payload. Development of ADCs is challenging because ADCs are very complex combination products for which there is minimal regulatory guidance.

The rapid increasing trend of novel ADC products includes a variety of antibody-drug linker conjugation technologies, drug payloads, linkers, and mechanisms of action creating new challenges in the development, manufacturing, and controls of these increasingly complex products.

The presentation will focus on the following points:

• FDA approved ADCs and new trends in payload drugs, linkers, and conjugation reactions.
• Overview of the Food and Drug Administration (FDA) review process for ADC products.
• Regulatory expectations on payload-linker, ADC drug substance, and ADC drug product controls.