BioCentury
ARTICLE | Product Development

This year’s model

How tumor kinetics modeling is informing dose and candidate selection

February 17, 2018 12:24 AM UTC
FDA has itself used tumor kinetic models to determine postmarketing commitments for at least one drug: Lenvima lenvatinib from Eisai Co. Ltd. Lenvima is an inhibitor of multiple VEGF receptor tyrosine kinases.

Companies are answering FDA’s push for model-informed dose optimization in cancer by modeling how tumors grow and how tumor kinetics relate to outcomes. The models can support dosing decisions and help companies make faster, better decisions about which products and combinations to take forward.

On Feb 1. the agency convened a joint workshop with the International Society of Pharmacometrics to discuss model-informed drug development (MIDD) for oncology products. FDA is committed to a series of workshops to enhance the use of MIDD under PDUFA VI...