Idelalisib Approved for Follicular Lymphoma

The FDA announced yesterday that Idelalisib has been approved for treatment of three types of indolent NHL, including Follicular Lymphoma.

Also, it seems like the name is now being changed to Zydelig, to conform to the rule that all newly approved drugs have to have a Z or an X in their name, preferably both. Which stinks, because I finally learned how to spell Idelalisib without having to look it up every time.

This is excellent news. Idelalisib/Zydelig received Accelerated Approval for Follicular Lymphoma, for patients who have had at least two previous treatments. Accelerated Approval means that the approval was based on results of a phase 2 clinical trial, rather than a larger phase 3 trial (though the manufacturer will still need to conduct another trial to confirm the phase 2 results).The trial that resulted in the approval involved 123 patients with either FL or SLL (another indolent lymphoma) who were no longer being helped by Rituxan or traditional chemotherapy. The study found that 54% of Follicular Lymphoma patients responded to Idelalisib/Zydelig.

Idelalisib/Zydelig is an oral treatment, taken in pill form. It is a kinase inhibitor, targeting and stopping a protein that is responsible for cancer cells thriving and growing.

The FDA's announcement, however, makes very clear that there are some side effects associated with Idelalisib/Zydelig (there are always side effects). So while the treatment looks promising, it's still something that needs to be discussed seriously with an oncologist.

Two big take-aways from this, I think:

The first and most obvious is that we have another arrow in the quiver. Options are good, especially options that seem to work when Rituxan and chemo stop working.

The second is a little less direct, but just as important: the FDA is making serious attempts to get treatments to patients through "Breakthrough Status" and "Accelerated Approval" processes. Traditional approval for Idelalisib/Zydelig would have meant months or years of developing, recruiting, conducting, and reporting on a phase 3 study. I think the Accelerated Approval is as important as the approval itself. My guess is it won't be the last one we see in the next few years.

PI3K delta, a protein that is over-expressed in many B-cell malignancies and plays a role in the viability, proliferation and migration of these cancer cells - See more at: http://www.gilead.com/news/press-releases/2014/7/us-food-and-drug-administration-approves-gileads-zydelig-idelalisib-for-relapsed-chronic-lymphocytic-leukemia-follicular-lymphoma-and-small-lymphocytic-lymphoma#sthash.VDHyLFWM.dpuf

PI3K delta, a protein that is over-expressed in many B-cell malignancies and plays a role in the viability, proliferation and migration of these cancer cells - See more at: http://www.gilead.com/news/press-releases/2014/7/us-food-and-drug-administration-approves-gileads-zydelig-idelalisib-for-relapsed-chronic-lymphocytic-leukemia-follicular-lymphoma-and-small-lymphocytic-lymphoma#sthash.VDHyLFWM.dpuf