Highlights

Generally, Vyxeos is actually quite tricky in my practice, because the labeled indication for it is patients who are 60–75 years old, plus therapy-related AML, or AML arising from MDS, or AML with MDS, or AML with myelodysplasia-related changes. So, those are the classical indications for the drug, however in my experience many of these patients in this age group who have these diseases are actually not suitable for intensive chemotherapy, and this is an intensive chemotherapy. So, you have to be fit, you have to meet one of those criteria, and while the RT label does allow patients who are younger – you know, the age of the patient, there is conflict between investigators with our younger patients if they should get the drug, I generally don’t give it for patients who are younger than 60, and I also don’t prescribe it for patients who have TP53 mutations.

So, if I have a patient who is 70, and has a FLT3 positive mutation, and he’s an intensive chemo candidate, I do give midostaurin, and I think this is partly related, in my view, to the more convincing biology, and the survival signal at four years in the RATIFY was 51% versus 44%, so 7% overall survival improvement. So, with adding the drug basically you are saving one out of 13 lives you are treating. I think in my view this is more convincing than Vyxeos, and this is why I’m extending it to patients outside the age of 60.