Priority Review for Duvelisib

The FDA has granted Priority Review for Duvelisib for Relapsed or Refractory Follicular Lymphoma (and for another blood cancer, CLL).

Duvelisib is a PI3K inhibitor (Phosphoinositide 3-kinase inhibitor). It works (as all inhibitors work) by stopping something from happening, in this case, some signals that cancer cells receive that allow them to live and grow and not die.

Duvelisib is different from other PI3K inhibitors in that it works on two different isoforms of PI3K, the delta and gamma isoforms. (An isoform is a different type of a protein -- the different isoforms do the same job, but they might be controlled by different genes. So an inhibitor that works on more than one isoform should, at least in theory, do a better job than one that works on just one isoform.) It is taken by mouth twice a day -- no ports, no infusions, no visits to the treatment room.

FDA Priority Review basically means the application will be looked at faster -- usually within 6 months. Regular Review usually takes about 10 months. Priority Review is given to treatments that seem to show an improvement in effectiveness or safety over other available treatments.

The FDA decision is based on results from the phase 2 DYNAMO clinical trial. In the trial, there was a 46% Overall Response Rate for indolent NHL patients, inlcuding a 41% ORR for Follicular Lymphoma patients.

OncLive has a nice, brief video from Dr. Lori A. Leslie that discusses some of the good and bad of Duvelisib and other kinase inhibitors. They are effective, though they have side effects that need to be considered. And while they are effective on their own, a better strategy might be to combine them with other agents, which seems to increase overall effectiveness.

As a patient, I am always happy to see another treatment move up the pipeline. Dr. Leslie discusses these in terms of eventually replacing traditional chemotherapy, which is also a great thing -- targeting lymphoma cells and keeping them in check.

As always, we'll keep an eye for the news of this the FDA's decision.