As you probably figured out, I like to share news about good things happening in clinical trials for Follicular Lymphoma treatments. And I really like to share news about approvals for new treatments.
And I am very aware that the news I share is almost always about FDA approvals -- those approved for use in the United States. Which makes sense, since that's where I'm from.
But I also know that many of you live outside the U.S. So FDA approvals don't necessarily mean much to you (though I get the sense, anyway, that FDA approvals give you some hope, if it means a new treatment might be available to you at some point in the near future).
I try to keep an eye out for any non-U.S. approvals, and I'm happy to be able to share a couple of them with here.
The first is from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The CHMP gave a positive recommendation for Duvelisib (also known as Copiktra). Duvelisib is a PI3K inhibitor (Phosphoinositide 3-kinase inhibitor). It works like other 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.It is taken as a pill, twice every day, which should make it easy to take (easier than sitting in a treatment room with an intravenous drip, anyway).
The CHMP makes a recommendation to the EMA, which then gives the final approval for use throughout the European Union. I don't known enough about the EMA to know how long that process will take, but from what I can tell, a CHMP recommendation is pretty much a guarantee that the treatment will be approved. So that means (hopefully soon) our friends in Europe who have had at lest two other treatments will now have another option.
The other recent approval is for a CAR-T treatment in Japan. The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Breyanzi (also known as Liso-cel) for aggressive Diffuse Large B Cell Lymphoma, and for Relapsed/Refractory Follicular Lymphoma. Breyanzi was approved by the FDA in February.
The price for the treatment has not yet been set, so I assume it is not available immediately. But I also assume that will happen very soon.
As much as I enjoy giving news from the FDA, it's even nicer when I come across news for those of you in other countries as well. I get to celebrate all over again.
And it's all a great reminder that there are great advances happening in the world of Lymphoma. Lots of reasons to be hopeful.
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