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iwAL 2025 | Should secondary AML be considered a distinct entity for regulatory approval and trial design?

Tara Lin, MD, University of Kansas Medical Center, Kansas City, KS, comments on the possibility of secondary acute myeloid leukemia (AML) becoming a distinct entity for regulatory approval and trial design. Dr Lin expresses hope for more tailored therapies for leukemia subtypes and excitement for future drug development. This interview took place at the 7th International Workshop on Acute Leukemias (iwAL 2025), held in Washington, DC.

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Transcript

CPX-351 was able to get an indication for secondary AML. I don’t know that we will see another large-scale study like that specifically for these patients. It would require getting upfront genomic data in order to identify that secondary AML signature. And I think you’d have to see a drug that had enough preclinical data in that subset before it would be taken forward. So I’m not sure that secondary AML would practically become a regulatory category unto itself...

CPX-351 was able to get an indication for secondary AML. I don’t know that we will see another large-scale study like that specifically for these patients. It would require getting upfront genomic data in order to identify that secondary AML signature. And I think you’d have to see a drug that had enough preclinical data in that subset before it would be taken forward. So I’m not sure that secondary AML would practically become a regulatory category unto itself. Philosophically, I would love to see that we could have much more tailored therapies for all of our different subtypes of leukemia. And when you look at the last 20 years in where we’ve come in terms of understanding AML biology in order to get rapid diagnostic testing on so many patients and develop these rich data sets. And then think about all of the drug development we’ve had and drug approval since 2017. Our drug approvals are still lagging behind what we know in terms of biology and being able to further identify subsets. So it’ll be really exciting to see what the next 10 years bring us in terms of drug development and drug developers looking in this space in particular. I think it’s important that for, you know, when we talk about secondary AML, that transplant is still a really key part of our treatment paradigm and patients who are fit for transplant and have an appropriate donor should absolutely be considered for transplant.

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