DR KANTARJIAN: So I think there are 2 studies that we need to highlight. The first one is the original study by Pierre Fenaux, which was an MDS study of azacitidine versus conventional care. And then they did a subset analysis of the patients who were 20% to 30% blasts. And they found that those survived longer with the azacitidine. That was the original study that suggested a potential benefit.

Then there is a second study, which is the one that was reported by John Seymour. And now this is in patients with AML with more than 30% blasts. Now, it is true that they cut the white cell count to 15,000, so what you see in both the conventional and the intensive chemotherapy arm, survival which is better than what’s anticipated. But if you look at the outcome of those patients, 488 patients 65 years or older, azacitidine versus conventional care, the median survival with conventional care is 6 months. With azacitidine, 12.7 months, p-value 0.03, doubling of the survival.

Now this could be trivial to some, but this is very important in the setting of leukemia. And I would certainly argue for an approval of the azacitidine for elderly AML. One could say, “It’s not important, because it’s available.” No, it’s important because it sets the tone that there are drugs which are approved in AML that we can use in combination without having to haggle with the drug companies.

And then the 1-year survival increased from 34% to 51%. So this is a drug that’s important the same way as decitabine was approved by the Europeans for elderly AML. I think azacitidine is along this path, and it allows us more weapons in our treatment armamentarium of acute myeloid leukemia.

Chronic Lymphocytic Leukemia (CLL)

Chronic Myeloid Leukemia (CML)

Acute Myeloid Leukemia (AML) and Acute Promyelocytic Leukemia (APL)

Myelodysplastic Syndromes (MDS)

Acute Lymphocytic Leukemia (ALL)