Pomalidomide Update

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Pomalidomide Update

by K_C_1 on Tue Oct 13, 2009 12:00 AM

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Good Afternoon Everyone;

I was in Philadelphia yesterday (Monday) visiting my MM doctor and I mentioned about waiting for the POM to come available June/July 2010.

My doctor told me he didn't think that was going to happen. I told him that I had spoken to people at Celgene and they informed me they were looking to make it available for public use mid 2010.

He said that was "optimistic thinking" as all the data he's read and medical people he's spoken to indicate that the FDA is not willing to place another drug on the market that offers little improvement over the drug it's intended to replace (REVLIMID).

Apparently POM has shown little benefit in either its affect on cancer cells or its reduction of side effects compared to REVLIMID.

Needless to say, this wasn't the news I had wanted to hear, Cath and I had placed alot of stock in this new drug.

Granted, this is only one doctor's opinion and I welcome any comments or data supporting either side of this issue.

Take care;

Kevin

RE: POMALIDOMIDE UPDATE

by djs45 on Tue Oct 13, 2009 12:00 AM

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The thing the FDA doesn't seem to realize is that a drug that's just a "little" different to a similar drug already on the market might be much better for a good number of patients.   

I was also looking forward to it coming to market because of the way Revlimid makes my white counts drop so bad after each round of treatment.

:)Dotty in E Tx.

On 10/13/2009 K. C. wrote:

Good Afternoon Everyone;

I was in Philadelphia yesterday (Monday) visiting my MM doctor and I mentioned about waiting for the POM to come available June/July 2010.

My doctor told me he didn't think that was going to happen. I told him that I had spoken to people at Celgene and they informed me they were looking to make it available for public use mid 2010.

He said that was "optimistic thinking" as all the data he's read and medical people he's spoken to indicate that the FDA is not willing to place another drug on the market that offers little improvement over the drug it's intended to replace (REVLIMID).

Apparently POM has shown little benefit in either its affect on cancer cells or its reduction of side effects compared to REVLIMID.

Needless to say, this wasn't the news I had wanted to hear, Cath and I had placed alot of stock in this new drug.

Granted, this is only one doctor's opinion and I welcome any comments or data supporting either side of this issue.

Take care;

Kevin


 


RE: Pomalidomide Update

by UTboy on Wed Oct 14, 2009 12:00 AM

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Kevin - as you know, there are many drugs and even more combinations.  I'm sorry the news wasn't what you were hoping for.  Personally, I think finding the right combination of drugs is just as important as individual drugs.  As you know, I'm not a strong believer in single agent use simply because my doctor has given me rational not to be.  I hope all is going well with the current plan and continues to do so.

The other writer's comment makes sense to me as well.  A little benefit for the FDA may still be BIG for some of us patients.

Take Care

Doug

RE: Pomalidomide Update

by poppycath on Thu Oct 15, 2009 12:00 AM

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Both Doug and Dottie make good sense Kevin, and like you I was first depressed by your doctor's view, however I now understand where he was coming from and don't put too much emphasis on his answer.  Revlimid, after 4 years, is starting to fail on me -- not badly yet, but the writing is on the wall and therefore my need is starting to become urgent!!  I am not going to panic at this point, but will keep a close watch on what is happening -- even if it means that I personally go and plead with Celegene when the case becomes desperate.  This seems to be the one drug which may make a real difference for me -- not in conjunction with anything else, but on its own.  I've had such a fantastic response from Revlimid and it has certainly been the magic bullet which has kept me going for the past 4 years -- and Pom hopefully may take me another 4 -- perhaps?!?! 

I'm sure that we have far more knowledge than most doctors on the medication situation for MM, both by being patients and by reading about all the reactions that others have had across the world.  Docs must rely on the clinical trial results and things which have been done under strict scientific conditions.  For example, the fact that I don't use dex -- most people feel that they can't have chemo without dex, but I'm living proof for the past 5 years that Thalid,Velcade and Rev can all be taken without -- whether the results are the same as with the dex no one knows, but hey, I'm still alive and kicking and doing nicely thank you very much!!  But clinical trials always use dex, so therefore its always prescribed with these drugs, but unless you are like me and have extreme reactions to dex most doctors won't consider giving you chemo without it -- even if you complain that you don't like the side effects.  Docs have to play by the rules with prescribing tested, tried and true drugs in conjunction with others in the same boat.  For some reason the drug companies don't seem to test without dex -- and I'm using this as an example only!!

I'm just going to hang on -- keep my ear to the ground and eye to the computers -- and follow the ongoing saga with regard to Pom.  Hopefully by the time I need it the situation will have changed in my favour!!  If not, well, I'll deal with that when the time comes!! 

On a brighter note, my slightly fluctuating paraprotein level seems to be steadying out -- at the lower end of the spectrum and overall my health is better than it has been since I was first diagnosed.  This is fantastic because Kate and her partner Greg are going to marry at the end of next month and we plan to fly over for the celebrations!!  They visited last week and I must admit that spending time with those two lovely grandchildren - who I never thought I'd live long enough to meet -- was the highlight of my life!!!  There certainly is a very special connection with those two -- and to be woken at the crack of dawn by our 2yr old Michael, with a golden smile and 'Hi Gramma Cath - are you awake?"  is the start to a MAGIC day - everyday.  I'm just so thankful to Celegene and Revlimid for giving me the past 4 years -- full of such special events!!  Sorry,but I'm a bit teary so I'll stop for now!! Love to you all -- Cath

RE: Pomalidomide Update

by Kkeating on Thu Oct 15, 2009 12:00 AM

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I agree - The FDA needs to look deeper - as any little change to a drug can make a big difference to a cancer patients response- especially myeloma patients. Just look at the start of Thalidimid. Who would have thought?? Any way- I am a 9 yr. survivor and have used Thal. with dex off and on for about a yr. then the past 11 months on low dose Thal. alone. It was very tolerable. I responded too and it kept my numbers (IGG/Mspike) down. So in 9 rys. I have been on drugs a total of approx 24 months.  You all have only written of Rev./dex or just Rev. alone. This new Pom. will be great too- if it gets past- as we all need options!  Have any of you tried low dose Thal.?  It seems some times low doses can work as well as high doses and have less side effects. Some docs still think the more the better?? I hope you can try other drugs or drug combos. I have met many patients and all of us are different and respond to different drugs,doses,combos,etc. So do not get depressed - there are many clinical trials out there too. Just continue to be proactive. Join a support group. Remember the IMF,  MMRF & the LLS, You will learn alot!  Check out Cure magazine too. This is a great web site too! Good luck, Kathy

RE: Pomalidomide Update

by wevebeenthere on Thu Oct 15, 2009 12:00 AM

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I agree, the news from your doctor is depressing.  The others make valid points.  Even a slight difference in a drug can make a world of difference to many myeloma patients.  From what I have read, Pom has helped even those that have failed both Rev and Vel.  That and the fact that Pom is related to drugs already on the market, would make you think that it would moved through the approval process more quickly.  It probably isn't going to help ALL myeloma patients, but there is a percentage that it will help and they should have the chance to try it.  Husband was set up to go to the Mayo Clinic for the Pom trials, but his numbers climbed too fast and he had to start Vel/Dex in June.  Numbers are back down now, but the trial for Pom is still at the back of our minds.  Not to put your doc down Kevin, but I hope his information is wrong.

Cath - just wondering - where are you flying to for the celebrations next month?  Would that be the USA? 

Take good care, everyone!

Jan 

RE: Pomalidomide Update

by K_C_1 on Tue Oct 20, 2009 12:00 AM

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Good Morning Everyone;

Please excuse the tardiness of my response, I've been fighting off a flu that is circulating around.

While ALL of your comments make complete sense, we have to keep in mind that Celgene is dealing with a government bureaucracy. These folks have no common sense. Or compassion! They're mindless drones.

Take care;

Kevin

RE: Pomalidomide Update

by wevebeenthere on Tue Oct 20, 2009 12:00 AM

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On 10/20/2009 K. C. wrote:

Good Morning Everyone;

Please excuse the tardiness of my response, I've been fighting off a flu that is circulating around.

While ALL of your comments make complete sense, we have to keep in mind that Celgene is dealing with a government bureaucracy. These folks have no common sense. Or compassion! They're mindless drones.

Take care;

Kevin


Kevin,

Amen to that statement.  Husband worked for the government for 30 years.  We never could figure out exactly what they were doing!!!

Jan

RE: Pomalidomide Update

by poppycath on Wed Nov 11, 2009 05:01 AM

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Hi Jan!!  I've just discovered the changes to this site and am now learning to navigate!!  Our wedding is in Adelaide, South Australia -- Fortunately all of our children still live in Australia so we only have to travel interstate to visit!!  And as Australia is no where near as 'developed' as the US, this means that we can literally drive for 8 hours at 110km and only encounter two stop lights on the entire journey!!!  At least this is the case when we head west!  Its a bit different when we travel up to Sydney which is a 12 hour drive with about 6 large cities along the way -- but 'large' is still not anything like the sizes that you are use to in the States and 'highways' generally mean 2 lanes in each direction.    All of this is not relative though as this time we are flying!! (one hour of travel instead of 8) 

Even though the Revlimid is still working so well for me, travel is not high on my list of things I enjoy doing.  The distances from the entrance of the airport out to the boarding areas is so  l o n g, and because we look so well I feel a bit of a fool sitting in a wheel chair being pushed out to the plane so I try to avoid it where ever possible!  Vanity, what a problem!!  Bob is exceptionally patient with me, but I know it would be so much easier for him if I would just take the chair and be done with the drama of trying to walk the distance.  I'm so focused on 'saving' all the energy that I can so that I will be able to spend it on what matters, namely the grandchildren and the wedding, that I may capitulate ....we'll see. 

But this is all about Pomalidomide and hopefully the comments of the previous posters point to the basic fact that it will come on the market -- eventually, and we just have to hang in there until it does!!  My results for the past 3 months on Revlimid have stabalised, so my fingers and toes are crossed that they continue in the same vane....at least until Pom is released!!  Cheers to one and all, thanks for your interest about the wedding!!  Cath

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