No More Duvelisib for Follicular Lymphoma

Taking a quick break from ASH reports to talk about some news from earlier in the week: The maker of the PI3K Inhibitor Duvelisib has taken it off the market as a Follicular Lymphoma treatment. 

In their statement about the decision, they said this was a business decision, and didn't have anything to do with its safety or effectiveness.

A little background, as a reminder: Duvelisib is a PI3K (Phosphoinositide 3-kinase) Inhibitor. It works by stopping, or inhibiting, some signals that cancer cells receive that allow them to live and grow instead of dying when they are supposed to. 

There are currently four different PI3K inhibitors approved for Follicular Lymphoma. They all work in the same basic way, but there are different variations of PI3K in the body, and they each work on a different variation (or two). They have been fairly effective when given on their own, though they seem to do better in trials when they are combined with another treatment. 

Duvelisib was was approved by the FDA in 2018 for Relapsed or Refractory FL. The approval was based on a phase 2 clinical trial, and the FDA gave Accelerated Approval for the treatment. However, because it was based on a phase 2 trial (which is usually smaller than a phase 3 trial, which typically provides the data for FDA approval), the makers of Duvelisib were required to continue with a larger trial before the FDA would give final, permanent approval. 

And that's where things got a little difficult. The statement said that the "current treatment landscape for FL patients in the U.S. and the logistics, cost and timing of the post-marketing requirements (PMR) for COPIKTRA [another name for Duvelisib] in FL was no longer merited." In other words, the costs of getting the approval probably wouldn't be worth the effort. They will continue to study Duvelisib as a treatment for T-Cell Lymphomas.From what I know, there is a lack of non-chemotherapy treatments for some types of T-Cell Lymphoma, so maybe it will help some folks over there.

It's unfortunate that we're losing a treatment option, but there are plenty still available, and more to come. 

This is a good time to remind everyone that I'm not a doctor or a cancer researcher, just a patient who reads a lot . But in my Cancer Nerd opinion, it seems like we're in a middle place right now. There are still some chemotherapy treatments available, and they're still very commonly used, and lots of doctors are used to them. But there are more and more non-chemo options becoming available -- inhibitors and monoclonal antibodies and bispecifics and CAR-Ts and combinations of all of them. Maybe too many of them to meet the demand that's here now, though there may be more demand in the future if they hang on? That's one possibility, anyway.

As I said, there are more new treatments on the horizon. The ASH Conference ends tomorrow, and we'll start to see commentaries soon about what the experts thought was exciting at ASH. I'll pass that along as I find it.