Good news for us -- the FDA has approved Duvelisib for Relapsed/Refractory Follicular Lymphoma.
Duvelisib, which is also known as Copiktra, was given Priority review by the FDA in April. The review looked at two clinical trials (the other one was for CLL/SLL, another type of slow-growing blood cancer).
Duvelisib is a PI3K inhibitor (Phosphoinositide 3-kinase inhibitor). It
works (as all inhibitors work) by stopping something from happening, in
this case, some signals that cancer cells receive that allow them to
live and grow and not die.
There are a few PI3K inhibitors out there. Duvelisib is different because it works on
two different isoforms of PI3K, the delta and gamma isoforms. (An
isoform is a different type of a protein -- the different isoforms do
the same job, but they might be controlled by different genes. So an
inhibitor that works on more than one isoform should, at least in
theory, do a better job than one that works on just one isoform.) It is
taken by mouth twice a day, which should make it easier to administer.
The trial that the FDA looked at was called the DYNAMO study. It involved 83 FL patients weho were refractory to Rituxan and then either chemotherapy or RadioImmunoTherapy (RIT). In other words, they had to have had at least two treatments that stopped working. (The approval is for these patients -- it's not approved as a first treatment.)
42% of the patients in the trial had a response (1 Complete Response and 34 Partial Responses). Of those patients who responded, 43% were still responding at 6 months and 17% were still responding at 12 months.
Like all treatments, Duvelisib has side effects. They include things like diarrhea or colitis, nausea, increased risk of respiratory infections or pneumonia, and problems with blood cell counts (among others).
Duvelisib is one of those treatments that a lot of Lymphoma experts have been excited about (see this interview with Dr. Lori Leslie, for example). It's another option, and I think that's always a good thing.
The numbers aren't spectacular (42% is very good, but it's not a cure by any means). It will be interesting to see where it goes from here. My guess is that we'll see it in combination with other treatments (that seems to be where things are going these days).
Overall, though, it's good news. Another arrow for the quiver.
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2 comments:
That is good news, having another option to choose from, especially for those who did not have the long remission hoped for from Rituximab.
I got good news from my 6 mo. CT scan today - little to no nodal growth, some nodes are less dense. (What does "less density" indicate for this disease?) I've not come across that word being used before.
Shelly
Shelly -- great news about the scan. Thanks for sharing -- I love hearing good news.
As for the dense lymph nodes, that's new to me, too. That phrase gets used in other cancers, from what I've read. They measure how many lymph nodes are involved in breast cancer, for example, and they compare it to the total number of nodes, and use the term "density." So more cancerous nodes means more cancer. But I haven't heard it sued for lymphoma. Maybe, if the report came from the radiologist who uses that term for other cancers, he might have thrown it in there. Whatever the case, I have to think less dense nodes have to be a good thing.
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