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ASH 2025 | The dosing and duration of venetoclax treatment for AML: balancing efficacy with tolerability
Pinkal Desai, MD, MPH, Weill Cornell Medicine, New York, NY, discusses the ideal dosing and duration of venetoclax treatment for acute myeloid leukemia (AML). Dr Desai shares insights into venetoclax use in both the induction and consolidation settings, highlighting that overuse causes excess toxicity. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So this is a very important question because as we know that the package insert for venetoclax currently requires 28 days both in induction and also in continuation cycles and there are guidelines that are telling us when to dose reduce. But in practice, we’ve actually moved away from a lot of those original trial, you know, sort of guidelines and package insert, because we realized with continued use that there is excess toxicity with a lot of venetoclax use...
So this is a very important question because as we know that the package insert for venetoclax currently requires 28 days both in induction and also in continuation cycles and there are guidelines that are telling us when to dose reduce. But in practice, we’ve actually moved away from a lot of those original trial, you know, sort of guidelines and package insert, because we realized with continued use that there is excess toxicity with a lot of venetoclax use. So for our practical purposes, what we have been doing is from an induction standpoint, we certainly give it for about 21 to 25 days and then have a holiday or a pause, checking the bone marrow potentially at that time and deciding whether you really have to continue venetoclax or not. And for consolidation, it’s actually not much data, but all anecdotally, we are doing about, you know, seven days, sometimes 14 days, depending on how patients are doing in real time. So some of the data that we’ve been discussing, you know, 14 days versus 28 days, there have been trials, randomized trials that are being done in this situation with somewhat equivalent, you know, results. And that kind of helps us understand that what we’ve been doing clinically is probably correct, that we don’t have to plummet much venetoclax, particularly in the post-remission setting. Now, the part that is very interesting is how this will impact ongoing drug development, because currently all of the frontline triplet regimens that are ongoing are sticking to the original mandate or package insert, and that’s because the FDA is wanting that to be in the protocol. And that is an interesting thing when you’re developing new drugs, because when do you annotate a toxicity that’s coming from the new drug versus overuse of venetoclax, dosing, or duration? And it’s a big deal in drug development because there’s maybe too much unnecessary reduction of your investigational drug when it should be reduction of the venetoclax dosing. So some of these data as they evolve are going to answer that question.
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