Thursday, April 27, 2017

Fast Track for Tazemetostat

The FDA has given Fast Track designation to Tazemetostat for Relapsed and Refractory Follicular Lymphoma -- FL that has stopped responding to treatment.

A few things probably need explaining.

First, Tazemetostat is an EZH2 inhibitor. There are lots of inhibitors out there for Follicular Lymphoma, some of them already approved, and some still in the process. They all work by inhibiting, or stopping, cancer cells from doing something that they need to do to stay alive. Different inhibitors target different things.

EZH2 stands for "Enhancer of Zeste Homolog 2." It's an enzyme that gets controlled by a gene with the same name. EZH2 is needed for an important step in cell growth called "methylation." Without that step, cells can't make copies of themselves.

Of course, too much EZH2 means too much copying of cells, which is pretty much what cancer is -- cells making more copies of themselves than they should, until it all gets out of control. Too m uch EZH2 can lead to a bunch of different cancers, including prostate, breast, and of course, Follicular Lymphoma.

An EZH2 inhibitor stops the cancer cells from doing that necessary step, and so keeps the cancer in check. Tazemetostat seems like it's going to be able to do that.

The other thing that needs explaining is the FDA Fast Track process. It's one of a few different programs that the FDA has developed to make treatments available to patients sooner than the normal process. Normally, a treatment would have to go through all 3 stages of clinical trials, and then have all of the data submitted at the end of the process. That's when the FDA starts its review.

With Fast Track, the treatment begins its review during the process, rather than at the end. This allows the maker of the treatment to have more communication, earlier, with the FDA. So if any problems come up (like with the way a trial is designed), they get answered and fixed before they happen.

For Tazemetostat, it looks like the Fast Track designation is happening just as they are getting ready to announce results for their phase 2 clinical trial, which will happen in June at the International Conference on Malignant Lymphoma (ICML) in Switzerland. They are making a big deal out of this announcement, so I'm guessing we'll see some good results.

To be clear, this doesn't mean that Tazemetostat is going to be approved soon -- or ever. (It won't be reviewed based only on the phase 2 trial results -- that would come from FDA Accelerated Approval). It does mean that Tazemetostat might be approved sooner than it normally would have.

Worth keeping an eye on. Inhibitors of all kinds are certainly going to be a part of our future treatments.

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