Umbralisib Approved by FDA

More good news for Follicular Lymphoma patients:

A few days ago, the FDA approved Umbralisib (also known as Ukoniq) for FL patients who have tried at least three other treatments. 

Umbralisib is a PI3K inhibitor. It is the fourth PI3K inhibitor approved for Follicular Lymphoma -- the others are Idelalisib, Duvalisib, and Copanlisib, which I just wrote about last month). They all work by blocking, or inhibiting, an enyzme called PI3K, which is part of a chain of enzymes and proteins that tell a cancer cell that it's OK to keep growing. By inhibiting it, Umbralisib (like the other inhibitors) turns off that switch and allows the cell to die like a normal cell.

The four inhibitors work the same way in general, but PI3K takes a few different forms in the body, and the different inhibitors work on one or more of those different forms. So there isn't necessarily a lot of overlap between them. They all do a slightly different job.

(Which one is best for you and your Follicular Lymphoma, should you come to a place where a PI3K inhibitor might be an option? No idea. Talk to your oncologist. She or he will know.)

The approval was granted based on a phase 2 trial that included 117 FL patients. (It was also approved for a different type of blood cancer with patients also included in the trial.) The Overall Response Rate for the FL patients was 43%, with 3% of patients getting a Complete Response. The median duration of response was just over 11 months.

Those aren't spectacular numbers compared to some other treatments. One big difference, though, is that is might be safer than other PI3K inhibitors. While it does have similar side effects, it will not come with a "black box" label, which indicates very serious side effects. That said, it still has side effects, including diarrhea, fatigue, nausea, and increased risk of infection, among others. And 18% of patients reported in the trial had serious side effects, especially diarrhea and infection.

My guess (and this is, of course, not coming from a doctor or cancer biologist) is that Umbralisib will end up being used in combination with some other treatment, and those numbers for effectiveness will increase.

The good news, though, is that there is another arrow in the quiver -- another treatment option -- for lots of Follicular Lymphoma patients. And another reason for hope.