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.
At the workshop, FDA officials championed MIDD as a means to determine the optimal use of new products when scant clinical data leave unanswered questions. A key focus was how to choose a recommended dose regimen when the clinical program has not fully defined exposure-response or exposure-toxicity relationships.
“Model-informed drug development offers us a pathway to answers -- perhaps less conventionally than we have answered questions through empirical clinical trials -- but to give us answers that are quite convincing, and that can guide therapy in ways we have not utilized before,” said CDER Director Janet Woodcock.
“Model-informed drug development offers us a pathway to answers.”
One way companies and FDA are using MIDD is to model the phenomena that explain how tumor sizes and rates of growth change over time. This modeling of tumor kinetics gives more information about how tumors respond to treatments than simple RECIST (Response Evaluation Criteria In Solid Tumors) criteria. As a result, these models can allow companies and regulators to draw more conclusions from their data.
The models have been used to justify proposed dosing regimens, design clinical trials and make go/no-go decisions