New Marketing Authorisation Application Submitted to EMA for Ibrutinib for the Treatment of Two Forms of Blood Cancer
The submission is for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL) and mantle cell lymphoma (MCL).
Janssen-Cilag International NV (Janssen) announced today it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ibrutinib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) or relapsed or refractory mantle cell lymphoma (MCL), two forms of blood cancer.
Ibrutinib is administered orally, once-daily and is the first in a class of medicines called Bruton's tyrosine kinase (BTK) inhibitors. Data suggest ibrutinib covalently bonds to BTK in malignant B cells, shutting down major proliferation and survival pathways. Ibrutinib is being developed by Janssen with Pharmacyclics, Inc. for the treatment of several forms of blood cancer. If approved, ibrutinib will be the first commercially available therapy targeting BTK.
"The EMA Marketing Authorisation Application is an important milestone in the development of ibrutinib," said Jane Griffiths, Group Company Chairman of Janssen Europe. If approved, ibrutinib will address a great unmet need for patients with CLL/SLL and MCL who have previously failed or become resistant to previous treatment."
The EMA filings follow the New Drug Application submission of ibrutinib to the U.S. Food and Drug Administration which was announced on 10 July 2013, for its use in the treatment of previously treated patients with CLL/SLL or MCL.
Dick
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The design of the Amazon server architecture used by HealthUnlocked, where Amazon have servers scattered around the world to supposedly improve local responsiveness, does have a downside in that it takes a while for content added on one server (e.g. one in North America that Chris's content would go to), to become synchronised with other servers around the world so that everyone has the same view of the site content. Thus it is easily understandable for two members to both cover the same breaking news near simultaneously and both be unaware that the other is doing so. I often wonder if I'll see that someone else has duplicated what I've contributed, particularly when you consider the process:
1) Check if a newsworthy item has a been posted to the site
2) If not, start entering a post (might take anywhere from a few minutes to half an hour or more if you are interrupted, or want to find a good image to accompany the post, which may need a bit of scaling and tweaking before uploading)
3) Submit your post
4) Snap!
And all this can happen without the added complication of recently added content not being visible to you due to the recent slowness (again) of the server synchronisation process and missed updates to the News feed/Latest activity pages.
The HU updates problem makes me think of the site software as 'acting' a bit more human. Who hasn't had the experience of heading for a room in the house to get/do something and along the way being asked something by another family member, getting interrupted by a phone call, seeing something needing doing, etc and then finally arriving in the room and standing there, wondering why you came there! Sometimes you've just got to laugh and carry on with life.
Mind you it is a bit of a concern when activity logs don't capture all the information - computers aren't supposed to forget. Perhaps HU should provide the Amazon server farm with a HU support site for forgetful computers!
This site has been so slow recently that this doesn't surprise me. I almost always get a message that says loading followed by one saying this is taking a while and it does. Sometimes I'm cut out and have to start over. Very frustrating.
I agree Pat, I'm seeing the same thing. I see no speed improvements, if anything load speeds are greater or the page just never loads. It may be faster in the U.K. with servers in Ireland, I don't know...
Pat and Chris, I suspect the site is just as bad here in the UK, as it is where you are. It seems to have got a lot slower this last week or so. Very frustrating. Frequent messages saying "this is taking a while" - and it certainly is. Sometimes it gives up entirely (or I do).
I've had the same problems again too, with page loading being incredibly slow. Sometimes it doesn't and I get timed out or server gives up trying! So I don't think it makes any difference, where in the globe we are physically.
OK so everything's on a go slow - so when do we expect to see the drug company submitting an application to NICE? Does anyone know the cost of the drug yet??
Do you have a list of CLL specific drug under development?.
I recall Chris has compiled quite an extensive list but cannot locate it..
I listened to Dr Wierda talk to us in London and seem to recall there were at least that many in CLL trial in the US? globally I think there are several more?.
I am trying to develop a picture of how many avenues are under development.
How many leave the test tube and mice to then enter human trial?
How many are in drug development stages?
How many are at licensing?
How many gain license?
How many are then approved for use by national guidance?
How many are funded by the national health systems.?
How many are available to regional health trusts?
In a trickle down process many don't make the grade or just fizzle out for one reason or other.
For each new drug you can click on ‘ Study Drug reports ‘ for full information on that drug and this very clever system will bring up hundreds of reports over several Google pages. Enough reading for a lifetime.!!
Karl is extremely thorough and a quick e-mail to him is likely to produce even more useful information.
thanks for this Dick this is a very good resource and yes will ask Karl if he has compiled something.
I guess the picture is even more complicated when we consider strategies and combinations of drug not just those in development as individual agents.
It is looking more increasingly likely that the most successful candidates with be combinations involving novel agents and established targeted therapies and or chemo. So the possibilities may continue to fuel the clinical trial well of future treatments. thus aiding treating clinicians who are very reliant on what is available in trial (as so few have been approved that work yet)? probably even more important to be with and expert now than ever if not now definitely in the future.
Also I believe (well a very knowledgeable friend told me) Only 3 cancer drugs in 100 ever make it through the approval process and into the commercial market..
The different combinations and the few that make it through should continue to fuel what is available to clinicians and ultimately us. The research phase is very important in more ways than one
well spotted error in the parent post has been corrected this was carried over from the original press release as it appeared in both posts entered around the same time..
I am now taking Ibrutinib, 3 pills per day, but very concerned that this very expensive drug is made in China, where I understand quality control of drugs is limited if at all. Is this true & should I be concerned. Why is this drug not made in the United States? Ruthyk
Drug manufacturing is a concern everywhere but the most egregious practices occur in China and India. Compounding pharmacies in the US have produced some lethal drugs not long ago.
Citizen pressure on our politicians to strengthen safety regulations to include frequent random testing of all drugs are key to minimizing unsafe therapeutics getting to patients. Patient safety is being compromised in efforts to promote so called "Free Market" trade agreements between nations. I have no problem with expanding free trade so long as home country higher standards of product safety, worker safety and rights are not compromised. The pharma companies, no matter where located, should be held responsible to guarantee product safety with severe penalties for corporate heads if dangerous products are sold to the public. Enforcement of strict regulations is key to the goal of safe drugs.
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