Good news and bad news for a potential NHL treatment called Pixantrone. It's moving toward approval in Europe, but its review in the U.S. has been delayed.
I haven't written about Pixantrone before, probably because it is being seen as a treatment for aggressive NHLs that have already been treated with CHOP. Since I tend to write about Follicular NHL, Pixantrone isn't really on my radar. Still, I see this as a potential fNHL drug someday, given its characteristics.
Pixantrone was developed as an alternative to anthracyclines, a type of drug that is very effective for some aggressive NHLs (there's an anthracycline in CHOP, which is the component that makes it so effective). Unfortunately, anthracyclines also cause heart damage. This is why patients can only receive CHOP once. If it fails, they need to look to alternatives like Stem Cell Transplants.
This is where Pixantrone comes in. Cell Therapeutics is looking for approval for Pixanthrone as a post-CHOP treatment for patients who cannot have a Stem Cell Transplant. Clinical trials suggest that it can be as effective as anthracycline treatments, but with much less chance of heart damage. Right now, there isn't really a treatment that fits that category of patient.
Yesterday, the European Committee on Medicinal Products for Human Use, somewhat similar to our FDA's review committees, gave a positive opinion for conditional approval for its use for those patients. There's still one more step before it is approved.
Unfortunately, in the U.S., an application to the FDA was withdrawn by Cell Therapeutics. A review was scheduled for earlier this month, but CT asked for more time to prepare, they were denied. This seems like a temporary set back -- they'll re-submit later this year.
I don't know how the approval process will go for Pixantrone, but, assuming it will gain approval, it seems possible that it would eventually be tested on other NHL patients besides their current target. Could it potentially be used on fNHL patients as another alternative, an effective way to delay CHOP, should it become necessary later on due to transformation? Or will it be saved as a post-CHOP alternative? Hard to say, but it seems likely that, should it eventually gain approval, fNHL patienmts will have to be a possible target in some way.
We'll keep an eye on this one.