Even More on Idelalisib

Yesterday afternoon, Dr. Jeff Sharman posted a brief video on his blog explaining what has been going on with Idelalisib. Dr. Sharman is a specialist in CLL and NHL, and serves as medical director of hematology research for US Oncology.I've linked to his blog before; he does an excellent job of describing things for patients (who are the main audience for his blog).

I'm glad he posted the video (which was produced for Patient Power) -- I have my own speculations about what has been going on with Idelalisib over the past few days, and Dr. Sharman confirms some of my guesses, and adds a lot more information (from an expert, not just from a Cancer Nerd).

Dr. Sharman points out that there is a kind of mismatch between what we know about Idelalisib and what these new problems in trials have revealed. Why was this approved if it seems to causing infections and deaths?

As he explains, this has to do with the patients in the trials. The earlier trials involved patients who has already been treated for CLL and Follicular Lymphoma. These newer trials involved patients with untreated CLL or lightly treated FL. Since the kinase that is targeted by Idelalisib is important to immune regulation, it's possible that interfering with immune regulation early in the course of disease (say, with patients who have never been treated or were lightly treated) has a greater impact than it would on patients who are later in the course of the disease (who have had it for a while and have had a bunch of treatments already -- like those in the earlier trials that resulted in Idelalisib being approved).

Makes sense.

And so patients who were treated early in their disease, and had their immune systems affected a lot, would be more open to infections -- their immune systems can't handle certain types of viruses.

For Dr. Sharman, there is some value in these trials, even though it resulted in some very sad problems. Basically, we have a better idea of how this works -- it might be a treatment that is better suited to people who have already been heavily treated.

For people still in Idelalisib trials, or who are taking the treatment, it's worth talking to their oncologist and making sure they are being watched very closely for signs of infection. If it's working, and you're not having problems, chances are good you can stay on it.

That was a great video -- very helpful in seeing the Big Picture, especially since the FDA statement was kind of vague.

we may hear more about Idelalisib in the near future, but I think it's probably safe to say that it will remain approved and available for people who have already been treated for their Follicular Lymphoma.