Thursday, July 24, 2014

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

4 comments:

Anonymous said...

I am enjoying reading your blog in the couple of years. I appreciate your updated information as my inportant source of blood cancer-related news outside of Japan. One thing about Idelalisib Approval news, I think 3 types of blood cancers are relapsed CLL, FL and SLL.

BR
AppleTree

Lymphomaniac said...

Yes, you are right. The FL and SLL approvals were "Accelerated," and the CLL approval was designated "Breakthrough" by the FDA. So the CLL designation is the biggest deal, but, of course, it's the Follicular that I'm most excited about.
Thanks for reading.
Bob

Ann Erickson said...

I just watched a short video on this By patient power & it was very encouraging. I posted a few months ago just before R-Benda regime. My midway scan showed significant decrease of lymphoma. The link to video is http://www.patientpower.info/video/fda-approves-pi-k-inhibitor-what-does-it-mean-for-patients-with-relapsed-follicular-lymphoma
Glad you had such a nice vacation. Although i have not posted many comments. I follow the blog regularly.

Lymphomaniac said...

Great find, Ann! Thanks for letting me know! I'll post something about it right now. And so glad to hear the B-R has worked so well for you.
Thanks for reading.
Bob