Dr Sean Khozin Discusses How FDA Regulatory Process Helps Advance Precision Oncology

FDA’s regulatory science activities are working to advance the field of precision oncology, in part by using predictive analyses to identify patients that may be good candidates for certain therapies, according to Sean Khozin, MD, MPH, senior medical officer at the FDA.

Transcript (slightly modified)

How does the FDA encourage advances in precision oncology?

If we look at the definition of precision oncology, as we all know we can best describe it as delivering the right drug to the right patient at the right dose. If you look at FDA’s approval mechanism, you’ll notice that the policies and procedures that have been put into place, in fact, are based on that very precise definition of precision medicine.

So in essence, when we review a marketing application, when we analyze the data, and do labeling negotiations, we ensure that the data supports the indication, the population of patients who are supposed to be treated, at the right dose. So that system has already been built into the approval process and the mechanism at the FDA.

Now, precision is a moving target and it’s driven by science. And it’s a very rapidly evolving field in oncology. Obviously, drugs are getting more targeted and more precise. So one of the ways, and one of the primary ways, that the FDA has been contributing to the advancement of the field is through its regulatory science activity. What we have been doing more, especially more in recent years, is looking at our own internal data and doing our own analyses, aggregated analyses on primary research to be able to identify for example populations of patients that may have certain characteristics that may make them a good candidate for certain types of therapies. We’re doing predictive analytics.

So that’s become part of the regulatory science process where we are doing primary research using our own data and also in collaboration with outside entities to contribute in a very proactive fashion to the advancement of the field of precision oncology.