Idelalisib No Longer Available for Follicular Lymphoma (in the U.S.)

The maker of Idelalisib (also known as Zydelig) has announced that it will no longer offer the treatment in the U.S. for Follicular Lymphoma (and for Small Lymphocytic Leukemia).

According to the press release, the FDA's approval had been based on a phase 2 clinical trial. It was expected that a phase 3 trial (with a larger number of patients) would be conducted, and if the trial showed similar results (a 54% response for FL), then final approval would be given. Partly because of Covid, the company had problems recruiting patients for the trial. They decided that it was better to withdraw the treatment from the market for FL and SLL. 

Idelalisib has also been approved for Chronic Lymphocytic Leukemia (CLL) in the U.S, and it will remain available for patients with CLL. It will also remain available for FL patients in the E.U, the U.K., Canada, Australia, New Zealand, and Switzerland.

I say Covid is "partly" to blame because, from what I could tell, Idelalisib wasn't a very popular treatment. The sales for the first quarter of 2021 (January to March) was about $16 million. That's a lot of money, but not compared to Yescarta, the CAR-T treatment made by the same company, which had 1st quarter sales of $160 million. 

I don't think that's a coincidence. Certain treatments seem more and more to be the future of Follicular Lymphoma, and based on the excitement that I hear when I listen to Lymphoma experts, CAR-T (and lately, bi-specifics) are going to be the choice of doctors, especially for relapsed/refractory FL.

If all of this sounds familiar, it's because just over a month ago, the maker of Duvelisib also announced that it would be pulling its treatment from the U.S. market. Duvelisib and Idelalisib are both PI3K inhibitors. There were 4 available, and now there are two.

I have to say, I'm not entirely surprised. Last June, I wrote a post where I asked, are there too many inhibitors available for FL patients? All four (and another being featured at ASCO) did slightly different things. But it seems like there wasn't going to be room for all of them.

And that seems to be the case. Losing two options like this doesn't mean that they are bad treatments. If anything, it might mean that they are good treatments -- good enough that 5 different companies want to get in on the action. If an oncologist suggests one, either alone or in combination, it's probably still worth having that conversation.

It probably says more about the state of treatments overall for Follicular Lymphoma, rather than any one individual treatment.

I know I always get excited about approvals for new treatments -- or even about applications for new treatments. When one gets approved, I usually say it's "another arrow in our quiver" -- another option for treating our disease. (That's the phrase that the Lymphoma specialist used when I saw him about a week after I was diagnosed. It's stuck with me for 14 years.)

And I'll continue to get excited about new treatments being approved. But maybe we're at a point in Follicular Lymphoma research where the bar is being raised -- where the newer options (R-Squared, CAR-T, bi-specifics) are going to be so good that we'll see fewer new treatments being approved. Instead, we'll see better treatments being approved -- treatments with greater effectiveness, or fewer side effects, than what we have available now. 

If that's the case, then you won't hear me complain. I'll gladly write less if it means we have better options available to us. 

(I'll probably still write just as much.)

Something tells me this is going to be a very interesting year for FL patients.