What are the current hypomethylating agents
being used, and how they are different.
There's two drugs available.
The first one was 5-azacitidine,
and the second one is decitabine.
The 5-azacitidine is given sub-Q
and intravenously
over seven days of treatment
and decitabine
is given IV daily for five days.
Decitibine was explored for a sub-Q
formulation, as well and oral formulation.
Sub-Q formulation did not...
...succeed.
Both, I mean, the 5-azacitidine,
will transform into decitibine
inside the cells—the substrate—to be,
to kill the cells.
And both were tried in a randomized trial
and both were effective.
In my mind, they are both equivalent.
You can use either one.
It can be administered
either sub-Q formulation or IV formulation.
I offer either way, either one to my
patients, depends on a patient’s preference.
I can tell you when you give sub-Q
formulation, some people can have pain
at the injection site.
If they have a low platelets,
they can have some small hematomas
and the patient may not like it
and they prefer IV formulation.
The IV formation is one hour infusion.
If I want to go my work, I'm in a rush, I’d
want to take the sub-Q formulation.
So I have two groups of patients, those
who will tell me I don't care about the pain.
I want a ‘in and out.’
I want to resume my normal functional life
activities and others, “I hate the pain.
I'm scared of the pain.
Give me IV formulation.”
So both are equivalent and both can be used.
It’s administered
intravenously over five days.
We have oral formulation, but they are different...
...different drugs.
In a way, I say the oral azacitidine
is different than the IV we give.
Different indication, different function
compared to the IV
formulation and then decitibine is given IV.
We tried sub-Q but that did not succeed.
So we have IV formulation given daily
for five days—so the standard of care.
We’ve explored
the oral formulation
where we assess the pharmacokinetics
of decitibine given orally versus IV,
and we found the best dose is equivalent
to IV formation when given orally.
And therefore today
we have either formulation.
Now that being said, the oral decitibine
is only approved for MDS, not yet for AML.
In AML is given off label,
but everybody is using it.