ASH 2024 | The impact of ponatinib on conception and pregnancy outcomes in patients with CML

This is one of the first studies that actually collects information about pregnancy and ponatinib. It was done together with Incite after 10 years that the drug was available for use in patients with CML. And we harvested approximately 20 patients that were treated during pregnancy or at conception for male patients with ponatinib. And as a matter of fact, we didn’t see that many differences compared to the other TKIs. We know that TKIs can be teratogenic, especially during the first period of the pregnancy, namely the fifth and the tenth week of pregnancy for female patients taking the drug. While for male patients, it seems that there are no problems in conception and in the product of conception. What was emerging was that in two patients that were exposed during embryogenesis to the drug because they stopped taking the drug around the sixth and the eighth weeks of pregnancy, they both developed in the baby Hirschsprung disease that is a rare condition in which there’s a malformation of the nervous system in the GI tract. It’s not a condition that is life-threatening but it’s something that rarely is seen and so we don’t know if there’s a direct relation with the drug but this is something that certainly needs to be studied a little further in the future. We then conclude that male patients, even if treated with ponatinib, can conceive safely, while female patients, it is important they stop treatment as soon as they know about the pregnancy, preferably between the fourth and the fifth week of pregnancy, not later than that.

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