The RadioImmunoTherapy Betalutin has been given Fast Track status by the FDA. This could be good news for those of us with Follicular Lymphoma.
Fast Track status means the FDA thinks the treatment will help with an "unmet medical need." The status is given to treatments that are fairly early in the development process, and the FDA will give some extra advice during the development, and might give it a faster review if and when the times comes.
So it's good news, but it still has a way to go.
The "unmet medical need" in this case is that Betalutin will be targeted at FL patients who have had at least two other treatments that have stopped working or didn't work in the first place (Relapsed or Refractory). The FDA agrees with the makers of Betalutin that there aren't enough options available for this group of patients.
Betalutin is a type of RIT. I wrote about it a few months ago -- you can watch a rally nice video here that explains how Betalutin works. It targets the protein CD37, which is on the surface of B cells (the blood cells that turn cancerous in Follicular Lymphoma. Many treatments for FL involve Rituxan, which targets CD20. When that stops working (so the idea goes) the Betalutin can target CD37, and get to those cancer cells that Rituxan couldn't get to.
As that video shows, Betalutin can attack the cells in a few different ways, and the radiation it emits reaches only about 40 cells away from the target cell -- not a very far distance -- so there isn't as much damage to surrounding (possibly healthy) cells as there might be with other treatments.
All of this sounds great, and the early trial results that led to the Fast track are (of course) promising.
But there's still one big problem -- will anyone be able to use it?
The RIT Bexxar was basically discontinued because it was too hard to administer, and the RIT Zevalin is way under-used. (I won't get into the details here, but you can scroll down the Lymphomation RIT page for more on why this is the case -- it's not because it's ineffective. In the U.S., it has to do with rules that determine who is allowed to administer it.)
That's a pretty big hurdle to get over. When the Fast track was announced, there was some talk online about this issue. As good as it might be, and even if it gets approved by the FDA, will it be as underused as Bexxar and Zevalin?
A Lympho Bob reader named Bjorn, who is a big fan of Betalutin, posted a document from Betalutin's manufacturer that lays out their strategy for getting the treatment to more patients in the U.S.
I understand the strategy, but (as I am happy to remind you) I am not an oncologist, a cancer researcher, or an investor in the biomedical sector, so I have no expertise to say whether or not the strategy will be successful. (Though I'm happy that they have one.)
I hope it is successful. I hope the trials show that Betalutin is safe and effective, and easy to administer, and meets the "unmet need" that some Relapsed/Refractory patients have. I have been fascinated by RIT since I was first diagnosed. It makes sense as a treatment, and Betalutin makes sense as a new approach to RIT.
Let's keep on hoping. We'll hear more about this in the months and years to come, I'm sure.
Thankks for the post
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