Tazemetostat: Priority Review

Last week, the FDA granted Priority Review for Tazemetostat for relapsed or refractory Follicular Lymphoma.

This could be god news for us -- another potential arrow in the quiver.

Let's break it all down.

Tazemetostat is an EZH2 inhibitor. Like all inhibitors (and there are lots of them these days for lots of different types of cancer), Tazemetostat's job is to inhibit, or stop something from happening. In this case, it inhibits EZH2, which is an enzyme that is controlled by the EZH2 gene. Basically, EZH2 is part of a process that allows cells to grow. When EZH2 does its job too well, the cell keeps growing. This is, of course, the definition of cancer -- cells that won't stop growing. By inhibiting or stopping EZH2 from doing its job so well, Tazemetostat can keep cancer cells in check.

Problems with EZH2 affect several different cancer, including Follicular Lymphoma.

The FDA application is for patients with relapsed or refractory FL -- basically, their last treatment stopped working, or didn't work at all. The approval would cover patients who have had at least 2 other treatments.

Tazemetostat had already received Fast-Track designation from the FDA a few years ago. I can't find anything in a quick search that says why it has been over 2 years with no action, but reports about the current Priority Review say that updates phase 2 trial results reviewed by an independent committee have been a factor. The trial involved 45 patients with EZH2 mutations, and another 54 with wild-type EZH2. The results showed that the treatment was well-tolerated.

[I'm also having trouble finding information about the difference between EZH2 and wild-type EZH2. I'm pretty sure wild-type isn't nearly as interesting as I have been building it up to be in my mind. I'm desperate for a little excitement in the Follicular Lymphoma Community.]

The last piece of the announcement is that the FDA granted Priority Review. This means that it will move the review process faster along than usual. They plan to have a ruling by mid-June of this year.

The company that makes Tazemetostat is also conducting a trial that combines Tazemetostat with R-Squared (Rituxan and Revlimid). These "triplets" are becoming more common, from what I can tell. They attack the cancer cells in three different ways, and so provide up to 3 times the effectiveness. Of course, they also provide up to 3 times the side effects, so that has to be balanced in there, too. Not much sense in having an effective treatment that creates more problems that it fixes.

I'll be sure to keep an eye out for more news about Tazemetostat and Follicular Lymphoma, in whatever form it is being studied. I'm al for another option for us.