Details and Analysis of the FDA Approved Indic... - CLL Support

CLL Support

22,512 members38,664 posts

Details and Analysis of the FDA Approved Indications for Idelalisib PLUS Links for Financial Help

bkoffman profile image
bkoffmanCLL CURE Hero
1 Reply

Hi Friends,

What a great week for us CLLers. First FDA approval of idelalisib, then the positive recommendation for approval for idelalisib and ibrutinib in the EU, then the surprising FDA approval of ibrutinib in frontline 17p deleted patients. I will be parsing all this on my blog, but first I spent a quite a lot of time studying the indications and usage and speaking with experts on the new label for Idelalisib (or CAL-101 or GS-1101 or now Zydelig) and there are some subtle surprises in those details that I review in my blog.

I also included some links to the Gilead and LLS websites that provide details of what they offer in terms of their financial and other support.

If you are interested, please check out bkoffman.blogspot.com

Thanks

Stay strong

We are all in this together

Brian

Written by
bkoffman profile image
bkoffman
CLL CURE Hero
To view profiles and participate in discussions please or .
Read more about...
1 Reply
AussieNeil profile image
AussieNeilAdministrator

Thanks Brian, for your informative blog that provides interesting background to the recent FDA approvals and explains some of the background to treatment approvals and off label treatment possibilities. Possibly good news too for those in the USA that medically qualify for the new treatments but face financial barriers in doing so.

To me, the first instance of different treatment for SLL compared to CLL is just an extension of the rapidly growing choice of treatment options, which make it practical to increasingly match individuals to the optimum choice for their genetics, prior history, age, comorbidities, etc. Exciting times indeed and hopefully increasing competition will enable the rest of the world, particularly those countries with universal health care, to catch up with the growing treatment options available in the USA.

Neil

You may also like...

Dr Sharman's thoughts on the race for FDA Approval for Obinituzumab, Ibrutinib and Idelalisib

Obinituzumab, Ibrutinib and Idelalisib and has written at length about the likely approval process...

Uncontrolled bleeding events with Ibrutinib and in general

has a special FDA approved drug Praxbind (Idarucizumab) but the FDA refused to approve the reversal...

Imbruvica Approved Frontline in the USA!

prnewswire.com/news-releases/imbruvica-ibrutinib-approved-by-us-fda-for-the-first-line-treatment-of-

Dr Sharman's survey to assess the CLL community's understanding of new treatments is now closed

know about the new drugs Ibrutinib, Idelalisib and obinutuzumab. His latest blog was a 10 question...

Ibrutinib denied to new patients

that the cancer drugs fund has removed Ibrutinib from its approved drugs list. Feels gutted for...