The FDA has granted Obinutuzumab GA101 in CLL both Breakthrough Therapy Designation and Priority Review.
Marketing applications have also been submitted to other regulatory authorities, including the European Medicines Association (EMA), in April 2013. In the United States, Genentech has opened an Expanded Access Program (EAP) to provide GA101 to people with CLL under certain circumstances while the company seeks regulatory approval.
gene.com/media/press-releas...
~chris
This looks very hopeful, though it seems to say it's just for untreated CLL.
I wish they wouldn't make up such complicated names for these drugs - so hard to pronounce, never mind remember.
Yes the names don't exactly roll off the tongue and get complicated by the totally unrelated trade name for the same drug. This one makes me think of Unobtanium, which for these new drugs is unfortunately an appropriate label for many of us.
en.wikipedia.org/wiki/Unobt...
"In engineering, fiction, and thought experiments, unobtainium is any fictional, extremely rare, costly, or impossible material, or (less commonly) device needed to fulfill a given design for a given application."
I like it!!!! I will certainly remember the name "Unobtainium" !!!! It will probably stay in my mind much more than other (real) names...
Welcome to the new kid, s/he carries a lot of hopes on his/her shoulders!
Hi Paula
This isn't a drug...it is a monoclonal antibody, mAbs, and it will shortly begin to replace Rituxan/Mabthera, in the next few years.
It will be used in the same way as rituxan, and perhaps as a monotherapy.
Mabs.... are named by convention...you can read more about here...
en.wikipedia.org/wiki/Nomen...
ama-assn.org//ama/pub/physi...
who.int/medicines/services/...
So, as you can see, the name of a monoclonal says a great deal about what it is, its use and
it's source, mouse, rat, etc...
HTH
Thanks for this, Chris. Very helpful. Rather complicated articles but they gave me the general idea of the naming processes. And it's made me realise I need to learn much more about the different treatments that might be ahead of me - including the working of MaBs as compared to "drugs".
The first of many?
It is good to have another effective first line treatment arriving for those unfit for FCR, buses often arrive together.
The GSK alternative monoclonal in a phase 3 study Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia (COMPLEMENT 1) is another in the mix. clinicaltrials.gov/show/NCT...
Ofatumumab is also a human anti CD20 monoclonal antibody that targets a different part of CD20 than rituximab genmab.com/product-pipeline... cancer.gov/drugdictionary?C...
I found this interesting and helpful article explaining the new kids on the block, "SIGNIFICANT IMPROVEMENT IN OUTCOMES FOR CHRONIC LYMPHOCYTIC LEUKEMIA: THE FIRST OF MANY?"
:snippet - concluding paragraph.
"Within chemo-ineligible/“unfit” newly-diagnosed CLL, where will obinutuzumab fit? As mentioned, development in this indication is crowded with promising new agents all seeking to transform the treatment paradigm. GlaxoSmithKline recently announced that the COMPLEMENT-1 trial of Arzerra plus chlorambucil versus chlorambucil monotherapy in previously untreated chemo-ineligible CLL patients met its primary endpoint by extending PFS from 13.1 months to 22.4 months (HR 0.57), which looks similar to the obinutuzumab results at the median, although the Hazard Ratios favor obinutuzumab (cross-trial comparisons with caveats). With this data, CLL will soon have three anti-CD20 antibodies to choose from. In addition, dinaciclib, ibrutinib and Revlimid are all seeking approval in this same patient population, and based on early trial results all have a good chance at being successful. A natural inclination would be to combine these agents with an anti-CD20 antibody, or potentially with each other, as well as bring these agents into the broader CLL population. CLL is very likely to be transformed in the next few years, with potentially more options than physicians know what to do with. We’ve encountered this problem before (renal cell carcinoma (RCC) comes to mind), but unlike RCC the influx of new agents in CLL have a large variety of mechanisms of action – an exciting turn of events!" - See more at: kantarhealth.com/blog/neesh...
A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714 AM2) clinicaltrials.gov/show/NCT...
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