[DaiCroParticipant]

[quote][b]FDA Approves Kyprolis (Carfilzomib) For Relapsed And Refractory Multiple Myeloma[/b]

by The Myeloma Beacon Staff

The United States Food and Drug Administration (FDA) has approved carfilzomib, which will be marketed under the brand name Kyprolis, for the treatment of people with multiple myeloma who have received at least two prior therapies.

Specifically, Kyprolis has been approved for myeloma patients who have already been treated with at least Velcade (bortezomib) and either Revlimid (lenalidomide) or thalidomide (Thalomid) and who have also progressed on or within 60 days of completing their last therapy.

Kyprolis, which will be marketed by Onyx Pharmaceuticals, works similarly to Velcade. Both drugs are in the class of drugs known as proteasome inhibitors. They work by preventing the breakdown of protein in cancer cells, triggering their death.

Additional details about today?s FDA announcement also are available in press releases from Onyx and the FDA and the Kyprolis prescribing information.[/quote]

Myeloma UK is a wonderful site and is 'Home' to me for both information and of course our community of friends. But our American friends send out emails by way of their 'Myeloma Beacon' dispatches with current issues and news from their patch… and their patch is where almost all new treatments, processes and procedures begin. 🙂

I subscribe to their newsletters and they are quite prolific. Some are parochial, some are blogs but most have something interesting to say or offer. It is not a community but it is news in the simplest and truest form of current and breaking information.8-)

Dai.

[AmelieParticipant]

I also read news from myelomabeacon – it is well done and easy to understand. They do also have a community – but not as good as this one 😀

[DaiCroParticipant]

Hi Amelie,

I subscribe to the newsletter for the information regarding new drugs and treatments but I have not tried to engage with their members board because we are always a year to eighteen months behind and so there is no dialogue that we can share on an equal basis. 🙁

The most interesting concept to come from the USA is there belief that less is more. Quite a few highly rated centres of Myeloma expertise are promoting lower doses of treatment and there is a move away from the SCT as the major goal of a MM patient. It is these sort of processes and procedures that attract my attention… that and the new drug regimes coming on board. 🙂

Dai.

[KeithH17Participant]

This is very interesting news but where do we in good old blighty fit in? Don't tell me we have to wait for those NICE people. The clock is ticking guys,get a move on.

Keith.

[scott9Participant]

Hi Dai

Many thanks for posting that. Let's hope it gets to the UK before too long. This might sort me out again as I had no success with Velcade. I'm on Revlimid at the moment but the light chain readings are creeping up. You are having the same problem I believe. My light chains have gone up from 127 to 152 but it seems this is no great cause for concern just yet. What's happening with your readings?

All the best

Scott

[DaiCroParticipant]

Hi Scott,

I am on Cycle 6 and my light chains have yet to settle which is a bit disconcerting but while they are yo-yoing up and down they seem to be staying within the same parameters as the beginning… so my consultant 'is not panicking'. I asked her about my Dex dosage and she said she won't consider a reduction until my light chains come down and stay down. 🙂 My readings so far (approximately):

Start: 300 – 225 – 128 – 212 – 175 – 125 – 210

So much of a muchness… but I am hoping to get them to 50 or under for the long term… the next reading might tell us something… as long as its not upwards I don't mind so much.;-)

So by comparison yours don't look so bad.:-)

Dai.

[terryl1Participant]

Hi Dai, you and I have communicated before about carfilzomib. I am an American and live in New Jersey. I am registered both with the Myeloma Beacon and Myeloma UK. I like both sites and their active communities. The Myeloma Beacon also has the added benefit of myeloma specialists who will respond to your questions in detailed fashion. The columns are also excellent. There is also an amazing resource which is the ACOR myeloma listserv which has close to 2,000 registered persons. It is second to none and is truly international.

As far as carfilzomib is concerned, I entered a clinical trial utilizing carfilzomib, revlimid and dexamethasone the first week of May, 2012, after my smoldering myeloma went active quickly. This trial is for newly diagnosed patients with no prior treatment. It is at the NIH (National Institutes of Health) near Washington, DC. So far, it has dramatically chopped down my disease and almost normalized my blood counts. In only two cycles, my paraproteins decreased 97%. For me, carfilzomib has been like a miracle. I have had a few bumps in the road and I am sure more will come, but I am focused on just feeling well today. Knock on wood….hope it lasts. I truly hope carfilzomib becomes available soon in the UK and elsewhere. When it comes to this condition, there should be no borders or bureaucratic obstacles. Cheers. Terry

[AmelieParticipant]

Hi Dai,

That seems very interesting! Are you thinking of the Mayo Clinic? I heard they are rather restrictive with too much treatment.

How can it be that USA is so much further than the EU? Is it possible for a EU citizen to have treatment in the USA?

Best wishes,
Amelie

[terryl1Participant]

Hi Amelie, during the course of my treatment at the National Institutes of Health (NIH), which is an amazing research facility (looks like something one sees in the movies), I have met patients from not only the US, but also Canada, Australia, Europe, etc. So, I assume there are no restrictions for care based on nationality, etc. There is no cost for treatment at the NIH if you are accepted into a trial. The myeloma section of the NIH is excellent and they have several cutting-edge clinical trials and will have more shortly. As far as the EU is concerned, my doctor at the NIH, who is originally from Sweden, when discussing research with me, indicated that Spain is quite advanced with regards to myeloma research and treatment. Spain is home to Jesus San Miguel and Joan Blade, two of the world's leading myeloma experts.

[AmelieParticipant]

Thank you very much Terry – it is useful information indeed.
I wonder how the patients from abroad financed the treatment?

In Scandinavia we have a public health insurance, which is a good thing, but I don't think it is easy to make them pay for treatment abroad. 🙁

Cheers,
Amelie

[terryl1Participant]

Hi Amelie, if the person is specifically treated at the US NIH (Bethesda, Maryland) in a clinical trial, there is no cost for the treatment. Obviously, there would be costs associated with accommodation, travel, etc. As far as private hospitals here, I have no idea if or how your NHS, etc. will reimburse for cutting-edge treatments like are done at the myeloma clinic in Arkansas, Mayo, Dana Farber, etc. Good luck! Terry

[KeithH17Participant]

That sounds like a good result Terry and long may it last. Carfilzomib does sound like a cracking drug and I certainly listened to very sound reports about it from Consultants at MM meetings I have been to recently.
What does puzzle me is that why do these trials all have to be repeated in Europe when it's patently obvious that the treatment works and that it's only going to prolong the wait and add to the cost. As we patients know time is something we don't always have a lot of so it's very important that these drugs are available to us when we need them,like you say no boarders or obstacles. If it's there,safe and proves to work then we should have access to it.
They are the only provisos that should exist and no others.

Take care and hope everything continues to go well for you.

Keith.

[scott9Participant]

Dai,

I think this web site is brilliant. It is such a comfort to know that you are not on your own, fighting this thing. I was pretty worried about the readings going up, but not so worried now that I see you are in the same boat as me. I'm not getting dex as I am on just maintenance therapy which is Revlimid (10mg) three times a week. My specialist said that so long as I don't start to feel a lot worse or my other blood results deteriorate then I should just carry on. I'm not too bothered whether the readings are 50 or 250 so long as nothing bad happens.

Lets hope we can both (and everyone else) carry on till this new drug reaches the UK.

All the best

Scott

[TinaParticipant]

Hi All

I may have posted this before but – I have been following the fantastic trials and tribulations of Lonnie Nesseler for many years. He is an American suffering from Myeloma and has come back from the brink on more than one occasion. He has survived an allogenic transplant from an unrelated donor and is currently doing well. A great blog to learn what the Americans have to offer

http://nesseler-medical.blogspot.co.uk/2012_01_01_archive.html

Best wishes to you all

Love
Tina

[terryl1Participant]

Hi Keith, the regulatory process does seem to be frustrating. I wasn't aware that the trials had to repeated in Europe. I certainly understand the safety concerns but there are sick patients who could immediately benefit from this drug and others in the pipeline. Carfilzomib/Kyprolis (what a mouthful) may not be a silver bullet but it gives us another potent weapon. Cheers. Terry

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