Dr Mark Fleury on 21st Century Cures and Cancer Care

The 21st Century Cures Act, in many ways, helps drugs in other disease areas going through review with FDA get to the same standard of the oncology area, said Mark Fleury, PhD, MS, principal of Policy Development and Emerging Science at the American Cancer Society Cancer Action Network (ACS CAN).

The 21st Century Cures Act, in many ways, helps drugs in other disease areas going through review with FDA get to the same standard of the oncology area, said Mark Fleury, PhD, MS, principal of Policy Development and Emerging Science at the American Cancer Society Cancer Action Network (ACS CAN).

Transcript

How do you think the provisions within the 21st Century Cures Act would impact cancer care in the United States?

The 21st Century Cures Act really was about trying to ensure FDA used its maximum flexibility and was really forward leaning in terms of how they handled drug development. FDA is a large organization and drug review is done by disease type. The oncology review divisions have traditionally been very forward leaning in terms of accepting novel endpoints, novel trial designs, smaller trials, and using more of the accelerated pathways. So, in many ways, 21st Century Cures, from a messaging standpoint, was telling FDA to sort of behave in that aggressive way across disease types. So, it was really an affirmation of the way the cancer review divisions were already behaving.

But one of the things it also did was formalize the Oncology Center of Excellence, and it was really a recognition that somewhere around 40% of all drugs being developed today are for oncology indications. So, it’s the biggest workload that FDA has, and there’s a recognition that that expertise needs to be shared across different reviews. And, also, the message is that FDA is not there to just simply review applications, but they’re really there to develop and promulgate better regulatory science, to help develop the tools that makes it easier and faster to get drugs to patients.