Dr Courtney DiNardo Sheds Light on FDA Fast Track Designation and Its Impact on Drug Development


Courtney DiNardo, MD, MSCE, the lead author on a study presented at EHA 2023 evaluating a new therapy for chronic myelomonocytic leukemia and acute myeloid leukemia, discusses the FDA Fast Track Designation for IO-202 and strategies for raising awareness and improving diversity in clinical trials.

Courtney DiNardo, MD, MSCE, a clinical researcher in the Department of Leukemia in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center and lead author on a study presented at EHA 2023, evaluating a new therapy, IO-202 (Immune-Onc Therapeutics) for chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML), detailed how FDA fast track designations impact drug development and how recuitment and diverse representation in clinical trials can be achieved.


How will the FDA fast track designation impact the development process for IO-202 as an AML and CMML therapy?

Having an FDA Fast Track designation is super helpful as you are developing an investigational agent because it really helps provide that framework of the clinical trial design and those relationships with the FDA so that the trial is moving and progressing in a way that, hopefully, can lead to an ultimate approval.

How can patient recruitment and retention be improved in clinical trials for AML and CMML?

Here, trying to improve recruitment is a really important goal. And I think actually one of the very few silver linings of the COVID-19 pandemic was the ability of creating just better networks across the country of telemedicine, of making different people ... and community settings aware of different trials that are available, and hopefully making access easier for patients that otherwise wouldn't be going to a major center. So, I think one of the most important things is awareness so that people, patients, family members, and community oncologists are aware of different trials and then, it's the actual process of getting the patient to where the trial is open.

What strategies can be implemented to enhance the representation of diverse patient populations in AML and CMML clinical trials?

It is a really important goal to try to make sure that clinical trials have a good representation of the patient population. And so I think it really is very important. And again, I think the ability of telemedicine, hopefully, to reach out and touch different areas—rural areas, urban areas, and patients far away from major academic centers—so that we can kind of touch patients that wouldn't otherwise be aware or accessible I think is a really important way not only to improve recruitment, like we were just talking about, but also to make sure that recruitment is a really well balanced section of the population.

How can collaborations between academia, industry, and regulatory agencies be strengthened to streamline and expedite the clinical trial process for AML and CMML?

Well, that is for sure the million dollar question. I think it is super important that we are all on the same table and talking together. You need the academic physicians that know the patient population and are helping to design the trials with industry with their new innovative clinical trials and novel molecules as well as the FDA, the regulatory people, that are going to be the ones reviewing and seeing does this actually represent a major improvement in our standard of care. We all need to be working together from the beginning, making sure that you know, we all believe in the agent and also, all along the way we're communicating and interacting with each other so that so that, ultimately, we we reach an answer as quickly and as efficiently as possible to really benefit our patients.


DiNardo C, Pollyea D, Aribi A, et al. A first-in-human phase 1 study of IO-202 (anti-LILRB4 mab) in acute myeloid leukemia (AML) with monocytic differentiation and chronic myelomonocytic leukemia (CMML) patients. Poster presented at: European Hematology Association 2023 Congress; June 8-11, 2023; Frankfurt, Germany. Poster P536.

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