Monday, March 14, 2016

Idelalisib Under Review

News out of Europe today:

The European Medicines Agency (or EMA, which is sort of like the FDA in the United States) announced that they were going to review Idelalisib, base on some problems from a couple of trials. One of the trials involves Follicualr Lymphoma.

Before we get to the reason, let's make sure this is clear: The EMA says that anyone who has been taking Idelalisib without any problems should continue to take it if it's working. There are many, many people who are in that situation -- Idelalisib has been great for them, and they have had no unexpected side effects.

However, in three trials in Europe, patients with CLL and with indolent NHL (including Follicular Lymphoma) have been having problems with infections. Unfortunately, some of the "increased rate of serious adverse events" have included patient deaths. The maker of Idelalisib has halted the trials, though they point out that the trials are not using Idelalisib in the same way that they have already received approval for them (the trials are looking at combinations for CLL, and the FL trial involves disease conditions that are different from those that the patients had when it was approved for them).

The FDA has not taken similar steps. According to one article, "The US Food and Drug Administration (FDA) spokeswomen Angela Stark: 'FDA is also looking into this serious matter in relation to the deaths of the patients during the clinical studies.' She added: 'The safety of patients is a top priority and the FDA will communicate new safety-related information on Zydelig as it becomes available'."

Some important things to consider:

First, Idelalisib has been working very well for a lot of people. This does not mean the end of Idelalisib. That arrow stays in the quiver.

Second, I read about a dozen articles that discussed this situation, and they were pretty much all from a business perspective -- sites for people who are interested in investing in the company that makes Idelalisib. And they all say the same thing. I haven't seen (yet) anything from a medical or oncology site that gives any kind of analysis. I hesitated to even write about this just yet, but I saw more and more articles about it, and I figured I should look into it. I'm still looking.

The kind of language the articles use is interesting -- they say the trials involved Idelalisib being used in ways "that were not approved," almost liken they had uncovered a scandal. Of course they weren't approved -- that's the whole point of a trial.

So my take on it, for what it's worth, is that this situation bears watching. I don't think Idelalisib gets pulled any time soon. It will mean watching patients more closely to make sure they aren't more prone to infections than suspected (and I'm guessing the increased infections are coming from Idelalisib doing its job of destroying infection-fighting white blood cells to begin with).

No reason to give up hope just yet.

But there's no reason to think any treatment is a miracle that won't come with some challenges either.

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