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Old 09-19-2011, 04:40 PM   #41
phil
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Re: Access to T DM-1

Sorry that I didnt get the link exact. Try again : http://signon.org/sign/fda-blocks-li...rl&r-by=603490
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Old 10-20-2011, 12:54 PM   #42
schoonder
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Re: Access to T DM-1


A recent WSJ article reported new FDA programs are being implemented by FDA Commissioner Margaret Hamburg to make the approval process clearer and more predictable for applicants. In particular elements in need to be improved upon were:.

1 - Timelines are long.
2 - Lack of clarity and consistency from FDA reviewers.
3 - Early dialogues between company founders and the agency will help smooth the regulatory process.
4 - New emphasis on personalized medicine, a burgeoning area that needs an updated approval strategy.
5 - Expedited drug development pathway for drugs that target threatening conditions and illnesses for which there is no great alternative already on the market.
6 - Unpredictability at the FDA.

http://blogs.wsj.com/venturecapital/2011/10/05/fda-tries-to-mend-fences-with-med-tech-start-ups-investors/?mod=google_news_blog

Since drug approval process is so closely tied to actual life and death issues, one would think Congressional Oversight Committee would assure immediate steps be taken to set right what now has been accepted to be a somewhat flawed approval practice, especially with personalized (targeted) medicine.
The T-DM1 refuse to file letter send to Genentech IMO was a direct consequence of a number of the shortcomings identified in that WSJ article.
There’s little to no risk involved for FDA to retract that RTF decision and to instantly start with examination of T-DM1 phase II results. Roche and partners are currently conducting THREE large, international phase III trials in 1st, 2nd and 3rd line HER2+ MBC setting. These data results when they are filed, the 2nd line study expected to complete by mid-2012, will guide FDA in further decision making.
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Old 10-21-2011, 07:21 AM   #43
phil
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Re: Access to T DM-1

Thanks Schoonder. Several of you have e-mailed me , asking if Lorraine got to switch tx. to Boston . She did NOT !! Genentech decided to close access , and with it the flexible tx. plan we had been working with in Va. That plan reduced the dose , because of low platelets. The cancer shrank more, and plats , still low , stabilized over the past 3 months. Now Genetech says Lorraine must meet " new criteria " for a " new study ". We were shocked. It had been portrayed as a simple roll-over , to a " maintenance " study. And Farber , the t dm-1 trial hospital in Boston, said that since it wasnt a full-fledged trial we could get treated by our doc at MGH. But she has never handled t dm-1. Partners IRB, which owns MGH, got involved. And we are stuck between the two. First the FDA, now this ! So, we have met w/ our Congressional reps, and had to go back to Va. this week. To stay in the flexible plan that Gen. and Va. worked out.
The south shore express article you included as a link, is better on paper than on-line. It was shrunk to fit on-line.
A few in-accuracies, and the pictures should be captioned : Before T DM-1 ( on adria last Nov., w/ our youngest grand dau. ), and After T DM-1 ( last week ). Those pics are worth the whole article !!
We fight on , David fighting Three Goliaths !
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Old 10-21-2011, 07:23 AM   #44
phil
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Re: Access to T DM-1

Dont forget , Sign our petition : " FDA Blocks Life-Saving Drug ", Google it !
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Old 10-21-2011, 02:05 PM   #45
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Wink Re: Access to T DM-1

I signed the petition when it was first published.
Have you checked on the phase 3 T DM 1Theresa trial to see if it will be availabe near you? It is listed on clinicaltrials.gov. You can also get more information from the Genetech trials information line.
All the best to you and your wife.
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Old 10-21-2011, 11:53 PM   #46
radiant
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Re: Access to T DM-1

Holy Cow Phil. I am just amazed at all you do! I read the southshore express article. It's terrific.

I am very sorry to hear that after all that work, you have to go back to VA. At the same time, it's INCREDIBLE news that Lorraine is down to ONE tumor. This is phenomonal news.

Very touching to read that you've both lost your 1st spouses to cancer, and are now in these shoes. Amazing that you two keep showing the power that "one" person can make.

Hugs,
kim
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------------------------------
Dx Stage 3C 2005, triple +, tons of lymph nodes as well. FEC, surgery, TCH, rads, herceptin 1 year. And, Aromasin.
2007 - recurrence to medistinal lymph node, Abraxene and Herceptin - took it down 50%
2008 - on Arimidex/Herceptin - stable lymph node.
2009 - stable on Arimidex/Herceptin
2010 - lymph node progression and liver mets.
2010 - went on Gemzar, Navelbine, Herceptin - Navelbine and Herceptin took liver mets down. lymph node slightly progressed.
2010 - did Xeloda & Tykerb - MAJOR progression in liver in only 6 weeks.
Dec 2010 - present - Ixempra/Avastin/Herceptin/Fasoldex - regressing
June 2012 - chemo break
Sept 19, 2012 - start t-dm1. Chose this over going back on Ixempra.
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Old 10-23-2011, 06:50 AM   #47
schoonder
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Re: Access to T DM-1

Phil, here are some recent excerpts plus link to opinions on FDA controversial MBC drug rulings.

"Steven Walker on October 18, 2011 5:33 AM writes...
T-DM1 did not just get dusted off. It has been in human clinical testing for a quite a while, many experts think it is already proven to be better than herceptin alone, and FDA (meaning Dr. Pazdur) refused last year to agree to an Accelerated Approval pathway, which imposed at least a 2 year delay (nd probably longer) on its availability to women with Her-2 positive breast cancer. That action by FDA was part of the same ill-considered campaign by Pazdur to eliminate Accelerated Approval. I am often perplexed by the tendency among some to automatically think that everything happening in the cancer space is about nothing but greed. Our system is far from perfect on all sides of the process, but virtually all the drugs we have that actually do effectively treat cancer arrive as the result of major efforts by drug companies, regardless of whether they were originally conceived by the drug companies or others. Women with breast cancer need drugs like T-DM1 - which does not contain Taxotere and is much less toxic. The new results are from a trial that compared treatment with T-DM1 to treatment with a combination of Herceptin and Taxotere. T-DM1 - which is much less toxic, proved to be far more effective.
Why doesn't anyone on this blog ever seem to consider the undeniable fact that sometimes (actually fairly often) the FDA is screwing up by delaying or sometimes even denying, availability of new (and old) drugs that work to patients who need them. It happens a lot more than you might think. Do some real research on what has been happening with T-DM1 and you might find yourself wondering why this drug isn't already approved by the FDA.
Incidentally, the "shelved" drug referred to in the article isn't shelved at all. Taxotere is still very much approved, still used and still quite toxic. It is exactly the kind of drug researchers and Roche are trying to improve on, and Genentech/Roche developed a combination of Herceptin and DM1 to try to do that. T-DM1 is a good drugm, a fact now known for several years from well-run clinical trials. FDA has been sitting on it, requirirng more data and refusing to fast track it - which by the way drives up the development costs by hundreds of millions of dollars - which in turn drives up the cost of the drug after approval. Please check your facts. You are simply wrong on this one. Genentech/Roche are not the problem here. The FDA (yes, Dr. Pazdur again) is the problem.
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18. ex-Pfizerite on October 18, 2011 2:03 PM writes...
Steven, most commentators on this board are people who work in the pharma industry and although we may seem cynical it is because we have seen to many positive phase II clinical trials that were not replicable in a powered phase III clinical trial. After a while in the industry you only believe a fully powered clinical trial and then you believe that trial only after it has been confirmed with another fully powered clinical trial. I believe that anecdotal reports are only indicative of something to study more closely via cell based assay or an animal model before even beginning to think about a clinical trial.
I also think that most of the people who read and comment on this board, while they may have had projects that they feel were delayed by the FDA or felt that the FDA had moved the goal posts, would also agree that the FDA does a very difficult job in an exemplary manner and making personal attacks on a FDA official is uncalled for.

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19. Steven Walker on October 19, 2011 8:09 AM writes...
To ex-Pfizerite: I am well aware that exposing the warts of our drug development system from the real patient perspective is uncomfortable for people who work in it. Sorry to crash your club, but you can expect patients and their advocates to be doing a lot more of that. From where we sit, the system is a disaster. In my response above, I was adding factual information to the discussion because the person who posted didn't spend the extra ten minutes it would have taken to understand what T-DM1 really is, and to also understand that what Roche is doing is not based on greed, but rather on exactly what we want the drug compaies to be doing - trying to bring better, less toxic treatments for serious diseases to market. In the case of T-DM1, a great many people, including many in the industry and some former high-ranking FDAers were very troubled (some were outraged) by FDA's decision not to fast track the drug and grant it Accelerated Approval based on early trial data. I am perhaps the nation's most focused and heeded expert on Pazdur's policy missteps over the last ten years, and his delaying action for T-DM1 was part of his aggressive policy enforcement efforts. This is not about a personal attack on Pazdur, it is about educating the public regarding a powerful official's misguided policies and the enormous negative effects those policies have had on patients (my first and primary concern) and progress against cancer (a very close second). Pazdur aggressively sought the role of oncology czar, and he has executed that role as an effectively unsupervised regulator within CDER, but in reality separate from the management structure of CDER. Because of these facts, confirmed to me by senior officials in the agency, Pazdur and his senior staff are in fact the cause of the policy problems, policies which he has clearly explained as being "his policies." They are not the policies of some amorphous "FDA." So how would you have us, the patient community, explain what we think the problem is? Use the term "unnamed FDA official/" For us, this is real life and death stuff happening in real time, to us. So how would you have us explain it? The problem is in fact Dr. Pazdur and his senior staff. Sorry if that huirts his feelings, but a dying cancer patient doesn't have time for beating around the bush.
Again, sorry to crash your party, but when people post things that are simply wrong, or take strong positions in the public debate that run counter to the best interests of real patients who will be directly, adversely effected in real time - expect us to speak up.
We think we are very important stakeholders in this process, and with all due respect, we are tired of being told by the traditional insiders that we should just shut up."

http://pipeline.corante.com/archives...ast_cancer.php
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Old 10-23-2011, 08:55 AM   #48
Ellie F
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Re: Access to T DM-1

Phil
What level of platelets do they accept in order to have T-DM1?
Thanks
Ellie
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Old 10-24-2011, 11:56 AM   #49
phil
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Re: Access to T DM-1

For trials they accept platelets of 100, 000 or above. Normal platelts run btween 150,000 to 400,000. The new " study " Gen. is talking about is an extension, for pts who have done well on the drug, and finished trials, access. So, they allow for a low of 75,000. Lorraine has gone as high as 71,000 this month. She is , as far as we know, the only candidate for this " new study " in Boston. Its a Catch 22, initiated by Gen. and running into a breuacratic repsonse so far from Partners / MGH IRB as well.
Al this highlights the difficulties thta Stage IV pts suffer in the current access/ trial system. I agree w/ Mr. Walker above . This particular T DM-1 issue started w/ Dr. Pazdurs team. I dont feel its personal when you call it as you see it. He and his team want to change the rules of Accelerated Approval. They didnt like what they saw w/ Avastin, and T DM-1 got caught up in that .
I think T DM-1 will be their stumbling block, its only out -performing very apporved drug out there. > And every researcher in the country was shocked when this FDA denied T DM-1. Its Phase II stats of 38% " complete or significant reduction " in Stage IV tumors speaks for itself. You dont havr to be " rocket scientist " to see the meaning of those no's. Those bloggers who defend this FDA about this drug are as " sincerely deluded " as Dr. Pazdur himself. Is that personal ? I dont think so, he sincerely believes that this Acc. Approval Program needs changing. He feels he is keeping Americans safe. Probably is , but not in this case. And he forgets tht we live in a Democracy, where he should not have this type of un-checked power.
Its not personal, when you deal w/ large Govt. agencies, or Global Corporations , its Very Impersonal. They all should spend more time in the chemo rooms, that might help change the System to be more " Stage IV Survivor Freindly " . Right now its causing un-necessary suffering and death. And its not just the FDA. Doctors are silent, Big Advocacy is silent, Big Media is silent Capitol Hill is silent. So we speak up !
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Old 10-24-2011, 02:37 PM   #50
Ellie F
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Re: Access to T DM-1

Thanks for the information Phil.I am full of admiration for your campaigning. As you know we here in the UK get what's approved in the States much later, hence the battle for tykerb! I sincerely wish you every success getting T-DM1 approved. The ppl who make these decisions have no understanding of what it's like to walk the path of a cancer patient and struggle to get access to these newer less toxic therapies.
Ellie
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Old 10-25-2011, 08:56 AM   #51
phil
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Re: Access to T DM-1

Roche/Genentech are starting trials in Europe w/ T DM-1 . Contact Gen. for details.
Re platelets, blood counts while on t dm-1. Someone e-mailed me about sharks liver oil. Lorraine has been taking it , along w/ chlorophyll, and 1,000mg. folic acid. The sharks liver oil seems to have helped her red counts actually ris to their highest level in 5 yrs. Not 100% sure, also, may be helping her plats stay in 60,000 -70,000 range. Along w/ dose reduction to 3.0, spacing tx's out more. We didnt start these supplements until after 7 full strength doses, and plats dropping below 75,000. Who knows if we had started earlier. All part of the learning process for those of you on t dm-1 , or starting.
That was the flexible plan for Lorraine in Va., that Genentech has now tried to change. And Partners IRB in Boston is delaying.
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Old 11-10-2011, 07:23 PM   #52
phil
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Re: Access to T DM-1

I promised to keep you all up to date. We continue to be stone-walled by top execs at Genentech, and forced by them to travel to Va. Thats the truth, and they continue to try to blame Partners IRB. We know different. Some of you out there in Calif. will have to try and explain this co. to us. Brilliant researchers, callous businessmen, breakthroughs and blunders. Movie material. Dr. Mukherjee ought to write a book on Gen. alone. Has anyone ? Its definitely tragic for women/men asking for a chance , at single pt access.
Dont forget this FDA, the " 1,000 lb gorilla in the back of the room ", punishing Genentech for pushing a true miracle drug... and trials drag on, 5 years ...
Back to Lorraine. Just got back from Va. yesterday. Second dose working well, tumor markers at continued all time low, 14. Thanks to generous family, friends, it cost us " only " 400 $ , cheapest yet.
Seriously, this has only increased the strain on Lorraine. When will it end ? we fight on...
Oh, those new to this site, Genentech monitors it, so keep that in mind, speak your mind. I do.
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Old 11-10-2011, 07:27 PM   #53
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Re: Access to T DM-1

Correction, second dose since Gen. told Lorraine she would have to meet new " criteria " for anew " study ". 13th dose over past year, 7 at 3.6 strength, 5 at 3.0. Great results, great quality of life. Stable platelets.
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Old 12-18-2011, 06:15 PM   #54
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Re: Access to T DM-1

We had our FDA Blocks Life-saving Cancer Drug Rally. You can see Lorraine on youtube at " Boston FDA Rally ". We will get an edited version of all 5 Speakers out soon. One of the speakers , Peter , is in the Pertuzumab/T DM-1 / taxol trial. he is doing great ! Counts dropping w/ just afew doses. Definitely worth looking into. You may or may not get pert., but you do get t dm-1. The trial w/ T DM-1 and GDC0945 also worth alook, because you get T DM-1.
The Petition was delivered to Sec. Sebelius. We would like to continue growing the pet. until we get a meeting w/ Sec. Sebelius in DC.
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Old 01-12-2012, 09:09 AM   #55
phil
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Re: Access to T DM-1

FYI, " Our Her2 Cancer Struggle " ( on FB), has posted the Video of our December " FDA Blocks Life-Saving Cancer Drug Rally " on Youtube. Please watch all 4 Parts, and pass the links on to your media,advocacy and political contacts ! We Are Not Going Away !!
Heres the link to Part 1: http://www.youtube.com/watch?v=JlsrTqwUL6g
And , yes , Lorraine is still being forced to travel to Va. to get Herceptin T DM-1. Even though she has no visible disease, and has been stable at 3.0, every 3 weeks, since last July !! At the highest levels of bureaucracy, Genentech , Partners, FDA, you have folks who see only " black or white, statistics, numbers, ". These Execs have No contact w/ pts in chemo rooms ..rules are rules etc. " Thats why we must Speak , and be Heard ! This is about Saving Patients Lives !!
We dedicate the Rally Videos to all those Stage IV Her2 + FIGHTERS who never got a chance to try this miracle drug in 2011 ! Approval Must Come in 2012 ! Speak up , make the calls , and FOLLOW UP w/ more calls !!
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Old 01-12-2012, 02:00 PM   #56
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Re: Access to T DM-1

Phil,
You did a fantastic job in showing how firmly the FDA is choked up with obsolete regulations that deal with approval process of lifesaving, state-of-the-art drugs and the consequences. Of course it goes much deeper than that, first with FDA Oversight Subcommittee failing to take any action to overturn this abominal ruling and secondly, a media more interested in reporting on an assassinated nuclear scientist, or a body found on grounds belonging to the queen of England, or Gingrich calling Romney a liar and the like.
The clock is ticking, HER2+ MBC patients are dying and nothing is being done to "expedite" approval of T-DM1.
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Old 01-19-2012, 07:30 PM   #57
phil
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Re: Access to T DM-1

Lorraine made it to Boston ! She did it on her own ( Really a God Thing ! ), her platelets hit 80,000 this past Monday. had a CT Tuesday - No Detectable Disease ! T DM-1 in Boston today ! After 16 trips to Va.
I will never complain about Boston Rush Hour Traffic Again ! Her story is a Testimony to Flexible Treatment for Stage IV Fighters, she got some chances, extra time, dose reduction to 3.0. And her platelets slowly responded , lows were less low than before, like a step-ladder. They "took off " 2 weeks ago, rising 19,000 in 9 days, biggest jump ever, so she could get treated , it turns out, on the 19th. Since she was a young girl, her " lucky " no. has been : 19 !
Thanks to the clinical teams at Va., Genentech , she s made it so far. For those who havent seen her go to : http://www.youtube.com/watch?v=JlsrTqwUL6g.
This FDA needs to be Investigated. Genentech needs to give single pt. access to Stage IV Fighters who have exhausted all other options ! The Drug Works ! Shame On Them ! Lorraine is Living Proof : Flexible Informed Choice Treatment Saves Stage IV Lives !
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Old 01-19-2012, 08:48 PM   #58
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Re: Access to T DM-1

Hi Phil,

I hope you wife can continue to get this treatment. I'm towards the end of my Herceptin treatments, I was stage 1B, had neo-adjunct therapy. If you don't mind, I have some questions for you about Herceptin. I am trying to get educated, because with being HER2+, I feel like it's difficult to truly move on. If your wife was ever on Herceptin, what side affects did she experience? I didn't even know about the new drug TDM-1, is it suppose to be a better drug than Herceptin? If so, why? How does one even know whether or not the Herceptin is working?

Thanks for getting back with me.
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Old 01-23-2012, 07:23 PM   #59
phil
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Re: Access to T DM-1

Hi Oregon :
All her2 + pts should be GREATLY encouraged by the development of Herceptin T DM-1. It is the best tx. for Her2 + since the invention of original Herceptin. Researchers have told me they think it will largely replace Herceptin over the next few yrs. Because it takes a chemo, t dm-1, directly to the cancer cells only , and blows them up ! There is no other drug like it in the world ! We just need to get This FDA to stop obstructing it ! They can't deny it forever ! ( another yr at most ).
My wife took herceptin for yrs, without s/e. Some pts have cardiac s/e. About 20% of her2 pts respond well tojust herceptin alone. The other 80 % need chemo. Herceptin T DM-1 attaches a chemo directly to herceptin, much more powerful than other chemos. It does affect platelets in about 30 % of pts, but that issue will improve when its approved, w/ more flexible dosing.
As far as knowing if herc. is working : do your regular follow-up w/ scans , tumor marker tests. And you know your body best , any symptoms , tell your doc you want a check-up. Any other ? , let me know.
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Old 01-24-2012, 10:39 AM   #60
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Re: Access to T DM-1

There's a relatively small t-dm1 phase1 trial, focusing on candidates with normal, mild and moderate impaired liver function, about to get underway in Canada, France, Italy and Spain. Trial particulars can be found at:
http://www.clinicaltrials.gov/ct2/sh...tansine&rank=1
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