Crunch time
I have written several full length articles on the subject of my favorite monoclonal antibody, Humax-CD20. The technical name is ofatumumaband for reasons known only to themselves, the owners of this important drug (GlaxoSmithKline) have chosen the trade name of Arzerra. Who comes up with these names anyway? Sounds like a new car from South Korea, if you ask me. I bet we could have come up with a better name if anyone had thought to ask us chickens.
No rest for the weary
The FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting is scheduled for May 29 of this year at Orlando, Florida. They schedule a slot of time when interested members of the public may speak their minds, give the committee something to chew on. I keep my ear close to the ground on these things and my sense of it is that this is no slam dunk application just waiting for the FDA rubber stamp. I think we as a patient community have to do what we can to give this the good old push and shove and get it over the goal line. Otherwise we have no one to blame ourselves if things go south.
So, I will be packing my bags and heading out to Orlando, Florida. In keeping with our no strings attached policy, I will be paying my own fare, spending my own bucks to get to this meeting and speak on your behalf. Money makes the world go round but you have my word that no drug company will ever “buy” me with nice little junkets and freebies.
For now, what I need from you are your comments, your thoughts and ideas on why this is an important drug and why we want the FDA to approve it for use in CLL patients. I strongly urge you to use the “comments” section at the end of this article. That way everyone can read what others are saying, a terrific way of getting some brainstorming going. For those of you who are newcomers to the CLL scene, below are the links to the recent Humax-CD20 articles we published. Reading them again may be a good idea for the old timers as well, refresh your understanding of why this drug is important to us.
Does Humax-CD20 work? (latest)
A smarter monoclonal (background)
Down the road, I may ask you to do a bit of letter writing campaign to the FDA. I am convinced this is a drug we must have available to us. It works better than Rituxan, has fewer problems because it is fully humanized (as opposed to the mouse-juice of Rituxan) and in any case it is good to have a little competition going between the two drugs. Who knows, it might even bring the price down. Sigh. Heck, with a bit of luck our Canadian members might get hold of this drug before they finally get access to Rituxan!
What do you think? Speak up!
57 comments on "Should the FDA approve Humax-CD20?"
I am very new patient with CLL so I have a lot to learn I will read the articles suggested and get back to you. Thank you Chaya for all that you do on our behalf. I was at the conference in Niagara Falls and I was blown away with all of the good people there. I came away with knowledge and a feeling of community. I hope to have a good long relationship with you all. Susan Marr
Chaya
I’m fully behind all your hard work on our part. Thank you verymuch for everything u do.
As for the cd 20 of course we need as many options as possible
Let’s face it for some folks rituxan doesn’t even work.
Last month I just completed a clinical trial of FCR with lummi
As you know lummi is another cd 20 drug. So far so good.
But when and if my cll acts up it would be nice to know I have safer
Options. Please FDA give us choice to fight this with everything
Available.
Tony Viscardo
E mail nocomm@aol.com
Tony:
Thanks for the support.
Just a small correction for the other members: Lumiliximab (“Lumi”) is an anti-CD23 monoclonal, not another anti CD20 monoclonal like Rituxan and HumaxCD20.
We reveiwed the FCR + Lumi trial on our website. The idea is to get a pincer movement going, with CD20 on the CLL cells targeted by Rituxan and the CD23 marker grabbed by Lumi. F and C are there for the killing fire-power of chemo.
In addition to our comments and thoughts, you also need and deserve our financial support. I urge all who can, to go to the “home” page and hit the “DONATE” button at the lower left. Let’s all try at the very least to throw some dollars toward the trip and airfare expenses.
I’ve travelled down virtually all the therapy roads, including a transplant in ’05. I am now on campath.
PLEASE FDA! … APPROVE HUMAX CD-20. I know I will need it to continue down the road.
Thanks Chaya, we are so blessed that you have our backs.
Bob Larkin
Chaya
Humax CD-20 is an extremely important option for CLL patients. This drug is based on human clone instead of mouse clone, which means that in all likelihood we cannot become resistant to the drug. I was in a PCR trial in 2004, but with the advent of Humax approval that would be a better approach as I will need treatment again. Thank you for being our patient advocate & supporting us. We need all options to fight this dragon.
Anne
Dear FDA,
Thank you for considering Arzeera. As a Patient who has Cancer and who understands what I am up against, I urge, plead, and even strongly insist that you approve the use of Arzeera. To those of use with little or no options it will mean life or death. The risk vs benefit clearly supports its approval from my perspective as a patient. Some of us can no longer take Rituximab. Arzeera is the only other real option that improves the odds. We all believe in the principle of LIFE, LIBERTY, and PURSUIT OF HAPPINESS. Please allow those well informed patients such as myself the pursuit of further LIFE by approving the use of Arzeera.
Thank You,
Leo
Dear Chaya,
I have taken the liberty of making another donation to help defray your travel costs. I made a donation a few months ago to help keep the site up and running, but you do so much more than that.
I have an excellent, knowledgeable doctor here in Los Angles, whom I like, but who finds it impossible to impart any real information that answers many of the questions that I have. If not for CCL Topics and Update CLL Topics I would be completely at sea. You, and the sadly missed PC, have made so much a positive differnce to my fight against CLL that I cannot thank you enough. Please consider the donation a small token of my esteem.
Go slay them in Orlando!
Luke (11q deletion)
Chaya,
Like Susan I am new to the CLL scene and am very interested in the new therapies available. I did not make it to Niagra Falls but very much wanted to. I hope there is another conference next year. The FDA needs to push these through and give the brave folks with few options some additional hope.
Thanks so much, for new patients who get this difficult diagnosis you are a blessing
David
Dear Chaya,
Thank you so much for taking your time, energy, efforts and going to speak to the FDA about Humax. Being 1 1/2 years post diagnosis and just completed my first round of treatment with Rituxan, I am ever so grateful for all that have come before me. Seeing this disease as a chronic one and one to be managed for what I hope to be is a long time, the idea of something better than the benefits that Rituxan brings great hope. I feel great so far after treatment and if drugs are available that can be so beneficial without the side effects of traditional chemo, I urge the FDA to move on this now. I am only 45 years old and after learning of more and more people diagnosed at younger ages with CLL, treatments that prove positive through testing need to be moved forward to allow the people who need these to gain access.
Again, thanks so much for what you are doing and let the FDA know that many people support your work.
Michael
As a Canadian, I probably don’t cut much ice with the FDA in the US. However, patients whose options have run out, whether they are refractory to Fludarabine, allegic to Rituximab, or whatever, need an alternative to dying which this new monoclonal may offer them. They have nothing to lose. Nothing. So getting out of the way would be a positive gesture on the part of the FDA.
Patrick
I think the FDA should approve this drug. In the near future, it may be my only chance of survival.
Next week, I will start 6 rounds of Rituxan and Bendamustine. I have low platelets and my doctor believes it is a result of fludarabine treatment from 4 years ago.
A month ago did single agent Rituxin. My wbc was at 300k and virtually all were bad cells.
In short, I think the FDA should approve this drug because it may give future options to patients like me.
Thanks for all you do for us, Chaya.
–Rich
For Tony
My husband has CLL since 2004. He has been around the block a few times with FCR/PCR/Trianda, but is now refractory for all of them. He has the dreaded 17p deletion along with 11Q and 12 trisonomy and there is not much left to help him. Please for his sake and the sake of others in his circumstance, approve this drug.
Sincerely,
Lynn Tortorello
WE hope the FDA will approve Humax and we thank you so much for making us feel a part of your CLL family. You are our lifeline and hope, with a subject that we knew nothing about and now thanks to you , are able to ask some questions. Our contribution is in the mail to you. Ron & Sheila, NL, Canada
Thank you, Chaya, for your continued support! Sending a
donation to help you continue your efforts on our behalf.
Heartfelt regards,
A
Chaya- Thanks so much for supporting Humax. Speaking as an engineer, in general the second generation of a similar product far surpasses the efficacy of the first. I’m hoping Humax can target the CD-20 protein far more efficiently than Rituxan does today, especially in patients such as myself who have had Rituxan over 50 times. I continue to feel that Monoclonal antibodies as maintenance therapy have a definite place in the CLL treatment heirarchy given their relative lack of severe side effects; even though none of the Oncologists in Niagara Falls agreed with my strategy of Rituxan monotherapy.
Sincerely,
Malcolm
I’m so glad you are speaking for us, Chaya; no one can do it better. Of course we need this antibody, especially for those who cannot tolerate Rituxan.
Cathie
Chaya, Thanks for supporting Humax at the FDA. And for all your hard work.
Jenny
It might help to make the argument that rituxan is not only a valuable drug in itself, but it also works synergistically with many other drugs. Thus, rituxan has been combined with F, FC, pred, ESHAP and so on. Given its multipurpose value, any improvement of rituxan itself, as would be the case if Humax were approved, would provide very wide ranging benefits across a variety of treatments and patient populations. The versatility of rituxan makes it an ideal drug to improve.
Hope this helps and thanks for all your help Chaya
Doug
Prior to my wife’s MUD transplant she was required to take Rituxamab to help clear her CLL laden bone marrow. I’ll never forget that night. The “mouse juice” nearly killed her! The doctor was called to in to pull the plug on the infusion. If she didn’t get the mouse juice her marrow would continue to be non functioning. Her platelets were holding at less than 10. They had been as low as 2! It looked like here choices were…mouse juice you die; no mouse juice you die. That was her fate late one night 3 1/2 years ago. Had a humanized version of Rituxamab been available this wouldn’t have been a problem or concern.
Fortunately just as the doctor was ready to pull the plug on the infusion process her heart rate began to stabilize, her blood pressure improved, and the massive spasms she was experiencing subsided. She was able to tolerate the mouse juice and future infusions were never a problem.
With a drug like Humax these types of nightmare scenarios can be eliminated. From this writer’s standpoint approval of this drug is a no-brainer!
OK, sorry, will write something down this time. T’was great to meet you in person at the Fallsview Chaya. Yes, I’m sure PC is proud as hell!
I come from Edmonton, Alberta and at the moment believe to have an indolent variety of the disease, and Humax could be all the treatment that I would ever need for years and years to come, without toxicity!
Yes, pls pull me up onto this band wagon so we can yell out our pleas for help. The other day my hematologist was grumbling about some threats that the government was making about pulling FCR away from us!
Now I’m worried that money and the economic downturn will have a direct effect on our longevity, preventing access to preferred treatments, such as Humax20 or Azeera, or whatever they want to call it!
Chaya,
Thanks. While I can’t fly to Florida I am happy to write a letter as a patient/doctor on the need for this important drug in the treatment of CLL.
Let me know the time and place and I will fire away
Stay strong
Brian
hansoncllr
As a 3 time Rituxin junky I may need something new in thew future. Make it happen! I’m close to Orlando, so if you need a place to restup you cenr=tainly be welcome.
Howard
Dear FDA:
ARZEERA is a drug that we need in our arsenal to fight CLL. My husband has been a CLL patient since 2002 and he fights every day to stay healthy for his family. We apprciate everything that you can do to preserve life and to help people in the future who develop CLL. Chaya Venkat speaks for me and my husband and thousands more.
Thank you,
Elizabeth A. Havey RN
Chaya,
I’ll gladly write a letter to the FDA in support of Humax-CD20. Just say when and where.
Tim
Chaya
While I have not had treatment yet, as I am in wait and watch and smoldering away, I want the option available. I agree with getting Humax FDA approved. I also think it is time for another donation to help with the costs involved for your travel and time. Thanks for everything you do
I believe that ofatumumab will be more effective than rituxumab, especially for those of us using Rituxan monotherapy with declining response. Ofatumumab is fully humanized, rituxumab is “part mouse”. It is possible that allergic responses will decrease and treatment response duration will increase in some patients using ofatumumab for that reason.
It is also possible that response duration will increase in some patients using ofatumumab because of its different mode of action. It appears to attach itself to a different portion of the malignant B-cell, and to “burrow” into the cell deeper than rituxumab. It’s own malignant cell killing power, and ability to summon the body’s immune system to assist with cell-kill, may also result in deeper and more durable treatment responses in some patients.
I strongly support its approval by the FDA. Thank you Chaya for carrying this torch…Let us know what kind of support you might need.
Doug in NM
Chaya,
I am also brand new to CLL and considered an indolent case. But you know what happens to patients like me in Bucket A. We don’t always stay there. My first repeat CBC is next week – I’m shaking in my boots. I can’t think of one reason to disapprove a drug that can help people with an incurable cancer. Did you hear me FDA ODAC??? INCURABLE. If you or someone in your family had INCURABLE cancer how would you vote? Try to remember that when you are marking your ballot. Chaya – I live near Atlanta and if you are traveling through this area on your way to Orlando you are invited to stay here with us. My Golden Retriever Dexter would love to meet you, and so would I! Also, I hope my small donation will make a dent in your travel expenses. My husband and I are retired but this is a cause that needs to be in our budget. Thank you Chaya for being the front man (woman) for all of us. We wake up every day not knowing what our future holds, but with you in our corner, we have hope. Nancy
Tcd111
My wife has been around the block a few times and like Patrick, she is refractory to fludara & allergic to rituxian. She is scheduled to see Dr Stadtmauer at U of Penn next week for a follow up but time is getting short for her. It seems to me that as these new chemo drugs are developed, have run through trials and are seen to have a benifet, why not approve their use. We are not talking about an over the counter product that could possibly be misused but, in most cases, a very deadly, body damaging product that no one in their right mind would use, unless there was no other choice. Also my thanks to all you do.
I very strongly support the approval by the FDA of ofatumumab (Arzerra). I think it may turn out to be a real life saver and I will support you in any way I can. You are a wonderful advocate. If it comes to a letter blitz, I’ll be happy to do my share.
One other way that will help, I’m sure, is making another donation today, and putting some more money where my mouth is. I only wish I could do more.
Betty
I have asked the ODAC committee for a 15 minute slot. Let’s see if I get it. I will prepare my comments ahead of time and I will publish them on this site.
If it becomes necessary, I will publish the address, email and other contact information for a letter writing campaign. I will not let this one go by without a good fight.
The use of CD-20 antibody therapy has proven relatively safe and the numbers prove Humax is no exception. It works in a different way than Rituxan and should be added to the arsenal. Unless there is a breakthrough in vaccine therapy or transplants, CLL is going to be a disease that we co-exist with and treat to buy precious time. Because CLL is generally so slow moving and such an individualistic disease, the concept of large rigid double blind trials is impractical; it would take a 100 years to test every combination of cocktails on all the different subsets of patients. Considering the 6000+ people dying from CLL annually and the generally tolerable side effects of Humax- it should be approved and added to the arsenal. The cocktail FCR is currently the gold standard of CLL treatment and it evolved through trial and error over years as the side-effect profile of each individual component was understood and the combination proved beneficial to many patients.
Thank you Chaya, for being our eyes, ears and advocate!
A few calculations here:
Airfare: about $250
Hotel: about $100/night; standard room, Holiday Inn. Minimum two nights.
Food allowance: $40/day (the lose weight plan!) Minimum three days.
Transportation to and from hotels on both ends: $80 (could include shuttles or parking, etc.)
That means for Chaya to take on this effort on our behalf it will put her back around $470. Plus whatever other costs required not included on the back of my envelope.
It looks like we need at least 10 people to pony up $50 each to keep Chaya out of trouble. More if you can, less if you can’t. But let’s get this covered! Click on the Donate button!
Thanks again Chaya – you are vital to our very survival.
sjohn977
Thanks Chaya,
I will be making a donation.
If this drug helps even some CLL patients it should be approved. What would be the argument not to approve it???
Chaya,
Congratulations on your fine presentation in Niagara Falls.
Excellent.
Thank you for being our advocate before the FDA committee.
I appreciate the importance of Humax 20. More effective less toxic drugs are an imperative in easing the adverse side effects of a disease that plaques so many thousands of us in the CLL population. As a 72 year old patient in a large class older CLL patiens, we understand our quality of life depends on their good judgement. We are dependent on the scientific governmenral community to come to our asssitance and approve ARXEERA.
We are fortunate to have you present on our behalf.I hope others
will join with me in helping to defray your expenses.
Safe trip and gratitude.
Jean
I was one of the lucky ones in Bucket A who went almost 10 years without any treatment being necessary. Was lucky again and got total remission with flud/cytox in 2004/05. My luck changed when it came out of remission with the dreaded 17p- abnormality and am being told BMT is my only choice for my bellyflop into Bucket C.
We need the FDA to approve drugs more quickly that will give us more options, not to mention options with less risks.
Pam
To the FDA:
You have what we do not. No, not expertise, or a wide breadth of detailed medical knowledge. What you have is time. You can look forward to a retirement, or a long vacation, or maybe buying that cute little convertible sports car. Those of us with CLL mark our days differently. Will I be alive long enough to see my daughter graduate from university or get married? Will I be able to work long enough to even afford to pay for those university years or a wedding? Should I bother to pay into the company pension plan because I’ll be dead before I collect? I ask myself those questions every single day.
I don’t ask them out loud, but they are there, like guiding stars in the night sky, determining how I chart the course of what ever time I have left.
You also have something else that we do not have – the power to say yes. As patients we can advocate, we can protest, we can raise our voices and demand to be heard. But we cannot say yes to Arzerra.
I understand and deeply appreciate the tremendous burden of deciding whether a drug is, on balance, safe enough to be given to the public beyond clinical trial. It is a huge responsibility and many lives are at stake. But at this point I think the evidence is persuasive, the benefits, and dangers have been catalogued and what remains now is really about managed risk. Is the risk to my health and my life greater or lesser by having it approved. I would argue it is lesser.
So, dear regulators, in this case lives are at stake, mine included, and on balance I am willing to take that risk.
The irony is, that I may never get to take Arzerra. Between regulatory approvals, insurance coverage issues and the decision of my doctors about it’s effectiveness in my case, Arzerra may pass me by. But I have two children. CLL is familial. I have it, my father has it, and may children may too. So if for no other reason, I want this drug as an option for them, if or when their time comes.
As I think about it, i guess this burden is shared, I carry it for myself and my family, you for all CLL patients now and in the future.
Thank you
Dave Downey
In support of Humax CD-20.
Having been diagnosed with CLL twelve years ago, and gone thru two treatments, Fludarabine and most recently PCR, I’m well aware of the advances in our knowledge of this disease and its many permutations. While in these past 12 years much as been learned about CLL, where few if any of us are identical, and where many treatment options (arrows in the quiver) are needed to stymie disease growth and one day find a cure, or at least find treatment regimens that keep the disease in check. Considering the substantial time lags between treatment and determination of long-term outcomes, many treatment options need to be continuously evaluated to reach meaningful outcomes for those of us with CLL and just as importantly those yet to be diagnosed. For those being treated now and in the future, total disease cost (medical, family related, job related, etc.) will only be reduced by broadening treatment options now, not later. To that end, Humax (and its future permutations) must be thoroughly evaluated now to reduce long term cost of CLL, and related diseases.
Thanks Chaya – you know you always get my vote.
I support FDA approval of ofatumumab. It works better than Rituxan and is less invasive because it is fully humanized. What is there to think about?
hi chaya,
please let us know when and where to send our support or if there are other actions we can take like writing to our congressional delegates and senators—-
you are the best chaya—-
lynn collins
Sorry to have to post again – but my scribbles on the back of an envelope turned out pretty lame. Let me clarify:
Airfare estimate from Trvelocity – $250
Hotel estimate was for a “club” member so the real price for regular folks is $150 a night and I failed to double it for a two night stay — duh!
Then I failed to multiply by three days the food allouance. Again – DUH!!
Plus the transport allouance of $80.
New estimate is $750
(These are just my thoughts – I have not spoken with Chaya.)
So after updating my calculations I can see we were about to leave Chaya seriously in the hole! Sorry about that.
Anyway – now we are looking at 10 people at the $75 level or 15 people at $50 bucks a piece. Or a benefactor or two at higher levels to help us get over the hump.
Some of us can write letters – some can go in person – and some can visit paypal. Please do what you can. This is an important fight!
Again – sorry to have to re-post.
Best, Jim
Sorry to have to repost but my cost estimate scribbles on that envelope and subsequent math fell pretty short. Briefly:
And no – I have not spoken with Chaya — Just looking out for her. ;-)
Air fare estimate from Travelosity: $250
Hotel estimate turned out to be for “club” members – so the real price is $150 a night. And I failed to multiply that by the two nights estimate. Duh. So – $300
I also forgot to multiply the minimal food estimate by the three days DOUBLE DUH!! $120
Then the transport estimate at $80.
So the more accurate (and unconfirmed) estimate is more like $750.
That puts us in a place to need 10 contributors at the $75 level or 15 folks chipping in $50 each. Or better yet – a few benefactors helping make this happen at a more generous level. Let’s carry the financial load and remove that stressor from Chaya.
Some of us can write letters – some can show up in person – and some can visit paypal. This is important. Please do what you can.
Thanks again Chaya – we are behind you!
Once again — sorry to have to repost…
Jim
Jim,
We don’t mind the repost. Thanks for correcting the math – we all need to chip in what we can to help our beloved Chaya get our message across to the FDA. Afterall, she is fighting OUR fight for drugs that will ultimately save some of our lives. We appreciate the time you took calculating the expenses. Nancy
Johnny Eagle
We all have to make financial choices in our life. For most of us, CLL is priority 1. We need Chaya to continue her “Road to a Cure”. Let us all pledge and process our payment on this web site. The cure is at the end of the tunnel and we all can see the light. Let’s make it happen by supporting Chaya with financial support.
Full disclosure: Chaya is not aware of my comments.
Chaya, Like many others I need options! I’ve recently completed FCR with a PR, now I have to worry about the next option and my options are running our since I only had a PR with the FCR. Ofatumumab is more powerful than Rituxan so it has to be in my options. Thanks for representing us and we are behind this 100%!
Chaya,
I will be there to support a letter writing campaign to the FDa, once the need arises.
Thank you and God bless you for your continued dedication to CLL patient advocacy.
I too have not needed a treatment since a 2007 diagnosis, but when the time comes I would like the benefit of a wide range of options.
The need to lobby the FDA for approval of this drug is important.
Chaya,
I had FCM-R in 2005 and know that in the future I will be in need of treatment again. Reading the information on Humax-CD20, gives me hope for the future. The mouse-juice of Rituxan has helped me thus far, but how exciting to look forward to the availability of the fully humanized CD20. Having had the “big gun” treatment, I was fearful about the future. Now, I have hope and how can the FDA not approve HOPE? Chaya, we thank you for all your help and dedication in the fight against CLL. As you have supported us, we are with you every step of the way. A million thanks for all you do.
Chaya,
As you know, I am on chemo since January. Rituxan the month of Feb. and continuing oral chlorambucil since the end of January. My labs responded well and a plus was the disappearing large nodes under my
axillae and neck. I am doing well, low platelets and still somewhat anemic. The nodes returned. Obviously, rituxan, chlorambucil did not do the trick.
We all know fludara or treanda would probably do better but I am unable to take them.
I will be on chlorambucil another two months. I will see my oncologist and we will decide. Most probably to do nothing because the nodes were not the reason for treatment.
But as I have said before, I have been doing the CLL dance for 15 years and at any time, I could need the large nodes treated again.
Humax may not be the treatment for me but it certainly would be a plus to have an option.
Thank you , Chaya, for all you do.
As with everyone, my check will be in the mail. If at any time you would like me to write a letter, I would be honored.
Blessings,
Rita
Thank you Chaya for representing those of us with CLL. It was a little over a year ago when I was diagnosed and I am on watch and wait. During this waiting time I have learned so much through CLL topics. I believe it has helped me to be able to make better and informed decisions now and in the future. Since I am only 49 years old I would like all the options on the table for me that have been proven to work and Humax CD-20 is one of them. There are those of us who could possibly have many more years if the FDA would approve keeping this option open for us. I hope that you are successful in convincing them of that. Blessings to you and yes! I will be making a donation.
Laura
GeoYez
Chaya, again you show your dedication to our cause by giving generously of your time and treasure. PC must be looking down to you with profound pride. I, too, will donate towards your expenses and pray that your effort convinces FDA to approve Azeera. I am still in watch/wait but nearing treatment according to some count changes. To have a human-based drug option at the ready should increase my confidence when the time comes. The possibility of longer remissions will translate into more saved lives. We are all thankful for your undertaking this mission. Godspeed!
Chaya,
Thank you for all your help over the years. Rituxan maintenance therapy, some months after FR, left me with pan-cytopenia, and four months later delayed-onset neutropenia. Humax-20 would be a welcome addition to the chemical arsenal and would perhaps avoid these response problems with Rituxan.
Grifj
Chaya,
I am just adding my two cents worth despite others who have covered the same ground in earlier comments. First, going through rituximab more than once can be a problem becuase of its chemeric nature. I have been through it once, and the time is coming (soon perhaps) that I will need to go through another drug infusion. Having ofatumummab would be a big help to me.
Second, if oncologists decide to pair it with other drugs (chemo or non-chemo), there is a chance of reducing the unknown outcome because it is made of human cells in its entirety.
Good luck in the southland.
Barry
Chaya,
As you know my husband began using Rituxan in 2003. At the time it was very difficult to recieve the Rituxan monotherapy, but we thought it was very important to us as self employed people, we could not afford the side effects of chemo and the chance that he would no longer be able to work for periods of time.
The Rituxan monotherapy has worked very well for him, in spite of an aggressive disease he has remained very stable all of these years with no side effects, infections, fatigue, or resistance to the drug. We heard the usual comments that Rituxan does not give a cure, that it does not give a long remission, that it must be given on a maintenance type basis every year. Yet for six years it has kept his disease stable and him strong and able to continue work and life as normal.
It is very important that we have the option of Humax, this may give more people the chance to contain their disease for years. It may give us an option in case he does develop a resistance to Rituxan. I think it is an honorable goal to maintain this disease, since there is no cure. Humax is a very important step to the goal of keeping CLL under control with few side effects.
Beth
Thanks for all you do, Chaya, you are our advocate & our angel. If anyone can argue on our behalf, you can. We wish you success in Fla because we will all benefit. If you need a letter writing campaign just ask.
Chaya,
Count me in on wanting ofatumumab to be available for Terry, all of you or any of our children, should it be needed. It seems so basic. Would you choose medication from a mouse or from a human? I vote for the human meds, especially knowing the severe reactions the mouse meds can provoke. Thanks for asking for comments.
I wanted to ask the FDA members which they would prefer for themselves or loved ones, but that could sound sassy or mean-spirited and we need good will from these people.
As the spouse of a patient undergoing FCR therapy, I too will fully support Chaya’s efforts to advocate for FDA approval of ofatumumab. Once again she is selflessly donating her own time, expense and most importantly her expert knowledge on our behalf. Thank you and best of luck.
Chaya,
Please let me know when we should write and the address etc. I have read lots on this MAB and am convinced we need this in our arsenal. Should we stress that CLL is really an orphan disease with not enough attention, research and drugs paid to it? Thanks for going to Orlando and fighting for us. You are just the best.
Chris Randolph
Chris:
When (and if) it becomes necessary to mount a letter writing campaign I will be sure to publish all the details – who to write to, what points need to be stressed etc. Keep your ammo dry until then!
I agree with all the members who have posted their comments that this is an important drug for our patients. We will have no one to blame but ourselves if we don’t do everything we can to make it commercially available, asap.
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