T DM-1 Activism

[phil]

Please post on other boards , its on Inspire. Approval is getting close. maybe this Fri. ? This FDA is dragging it out, probably developing a defense of their mis-handling of this drug since 2010. Some signs include recent quicker approval of lesser drugs , ones w/ smaller target populations. Lately, This FDA has promoted " Black Box Warnings " on chemo drugs. Everyone knows that cancer drugs have s/e, risks; this is an FDA PR ploy. A defense of their slowness since Pres. Obama took office . ( We at Our Her2Cancer Struggle (FB) are non-partisan, but we " call em as we see em " ). This FDA is deliberately playing up risk. " We had to take due diligence , etc. "
Some of you have asked us about advocacy for this drug, and how to be true Activists, working to change This FDA System. The opportunity will come soon. When the drug is FINALLY approved, anytime from now until Feb. 26th, we must Seek Publicity. To keep this from happening again. To make sure there are no conditions on appr that keep it from early Stage IV Survivors. Start right now to look up your local, nat'l media e-mails. TV first , then print. Your local / national reporters who cover cancer-related issues. When appr. comes , we will post a Press Release here. With the " Real Story" , not This FDAs' excuses. With our website, http//:stageivsurvivor.webs.com . If you haven't visited lately, we have added Christi Turnages' Avastin story, and Darlene Gants' Pertuzumab story. More examples of un-necessary suffering caused by This FDAs' anti- Stage IV agenda. At that time , send out the Press Release to your contacts in media. If you are on T DM-1, you are one of the lucky few, add your personal story. Keep it brief. This drug will tell its Own Story, just like original Herceptin did in '96.

['lizbeth]

Keep us posted Phil. I can't wait to see TDM1 approved. This seems like such a major milestone in the treatment of Her2+ cancer. I just can't believe the progress in the last 5 years. The next 5 will be even more unbelievable, but the FDA will need to change significantly if they are truly serving the best interests of cancer patients.

Do you know if there are any current TDM1 trials for primary breast cancer?

[phil]

I don't know of any primary trials. I have focused on getting it appr for Stage IV . I have fears about how long it will take to get it to early stage. i hope it replaces TAC in future. you can call Genentech , 888-662-6728, ask. hope you all will send out release , to any media you know, one story could be the " One " that breaks open an investigation ! It had great stats in 2010, every leading bc researcher thought it would be appr., even now , This FDA has had preliminary data from EMILIA since before ASCO in June, final data since August !, incl. stats that SIXTY -FIVE PERCENT of T DM-1 pts in EMILIA are still alive after 2 YEARS ! 4 months out of the 6 month time -frame for " Priority " Review have elapsed . " Priority " ?? more likely a " CYA " Review !

[phil]

Another week gone by, still no approval. For over 4 months This FDA has been " studying " T DM-1, this is thier version of a " Priority " Review . a drug that they know so well... saw an article on -line from the San Fran Business Times, by Ron Leuty. brief overview of San Fran area drugs developed recently. Superficial, with in-accuracies , stating that Gen. gave data to FDA " last month " ( actually Aug. ), and that FDA rejected drug in 2010 because " pts in the trila had not exhausted all other options ". Actually , This FDA , made that statement about ALL Stage IV Survivors in this country, without ANY scientific study, without ever interviewing a SINGLE PT. ! I wrote Ron , w/ corrections, I 've talked to him before, seems like a nice guy, but like many business writers , not interested in the pt. perspective. So , you Stage IV's have to give it. Any of you in the Bay area who are lucky enough to have T DM-1, or are waiting for it, give him the pt. perspective. Maybe he, others, will listen to you. you have the stats from above on this post, and the website stageivsurvivor.webs.com. Thanks.

['lizbeth]

The cancer clinical trial system is unbelievable. Seriously. Should we let patients die in clinical trials to prove a treatment will work?

Think about it. How many people have died of cancer? Of a specific cancer. Why can't we have a standard, enroll everyone in the clinical trial in the new treatment. If they do better than the standard, the new treatment should be approved - first line, for everyone.

The entire medical system works against us, to prevent us from having new treatments. Think about it. The technology for Herceptin is decades old, and yet it was only available to primary breast cancer patients 5 years ago.

It is not just TDM1, it is the system. It is madness and it needs to change.

[phil]

This FDA seeks no input from the very Survivors they purport to be helping. Besides their un-scientific statement about pts " not having exhausted all other options " , they insisted on comparing t dm-1 to tykerb/xeloda . You Stage IV Survivors already knew that combo was inferior in 2010. Now nearly 3 yrs later , This FDA is going to tell you what you already knew. after they craft a defense of their actions . While hundreds more go past the point of no return. And they are un-touchable , Congress told us so in 2011. Their superiors in Sec. Sebelius' office told us the same earlier this yr. They don't care how good the drug is . This is where a good investigative journalist comes in. to prevent this from happening to another drug, to help us empower Stage IV Rights. we want a place at the drug approval table. ( Sen Kay hagan , NC pushed alaw to overhaul fda approval process, but there's no place for stageiv advocates ) I told This FDA , " In the end it really IS all about us ! ".
Tykerb was given early approval in 2007, under the previous , business -friendly Admin. Does anyone know how many yrs that took ? Un-like tdm-1, when was the trial process stopped ? What was the reasoning by That FDA ? Did they put a " Black Box Warning " on it ? Like This FDA is doing ? Like we dont know chemos have s/e , duh !!
We need consistency from Admin. to Admin. This FDA was hell-bent on punishing drug co's for not finishing trials , and wanting new , longer testing - using Overall Survival stats vs. the previous gold standard, Progr. Free Survival or time to progr. We can'tet them continue to ignore us , patronize us !

['lizbeth]

Phil,

It was a shocking experience to become a cancer patient. The cancer diagnosis was the least of my problems. Being a "good" patient was the most difficult. I hadn't a clue about "Standard of Care". I hadn't a clue about clinical trials and how they worked. When I started reading the results of different studies and showed up at my oncologists asking about them. Whoa, was I ever in deep shit. Any time I try to get more educated involved with my own care I get scolded for 'trying to be my own doctor".

Even doctors talk about their experience when becoming a patient. They may be experts in their own area - but upon becoming a patient they are treated differently, as second class. Any prior knowledge or expertise seems discounted.

So excluding Stage IV survivors from the very process that could save their lives - who is the system truly helping? You are right Phil, we need patient advocates. The medical community, the pharmaceutical companies, the FDA are all currently earning money from the way the system works. The patient has been minimized. Well, we can't possibly understand what is good for us, right? We need someone else to tell us, or so the ones who are currently in charge of modern medicine would like us to believe.

And yet, if the system was changed, everyone could still profit. And the patients who will lose their lives with the current system could be saved. Why do we sacrifice the most vulnerable? For the integrity of the data? Heaven help us, such an advanced society should be able to design a more compassionate system.

[chrisy]

Phil,
Maybe this is just my paranoia talking, but thought you might find this "draft guidance" re clinical trials interesting.

[URL="http://www.medpagetoday.com/Washington-Watch/FDAGeneral/36607"]

I may have messed up the link but you should be able to find it.

My evil reading of this: in order to speed up the approval process, the guidance is to " enrich" study populations to exclude those less likely to benefit. While this makes sense on the surface (include only her2+++ in trials of her2 directed therapy) and that example appears to be the intent, by extension this could mean excluding heavily pretreated or even ALL stage IV as they are clinically less likely to benefit than more "naive" patients.

Further, the mention that these "enriched" data be noted in the labeling. This is there potential for even more of the restrictive approvals such as with Perjeta?

Like I said, maybe it's just my paranoia talking, I guess any guidance and clarity
the FDA can give developers can help avoid some of the bad calls on TDM1. But this FDA is making it extraordinarily difficulty to conduct trials for Stage IV patients thus throwing out the very babies that need effective treatments the most with the bath water.

['lizbeth]

Chrisy,

I posted the article on the Her2 board under FDA enrichment. I think we should encourage all to take a look. I see pros & cons.

[StephN]

In some talk at San Antonio recently I heard such a thing mentioned (making the trial results more favorable by eliminating those patients "beyond rescue"). SO WHAT about people like Ginger Empy who was in the Phase I Herceptin trials and is STILL alive, as well as Barbara Bradford?

Maybe it was in the talk on "Clinical Trial Designs for New Therapies, 2 - 3:30pm, Educational Sessions, Tuesday, December 4. Moderated by Susan B. Hilsenbeck of Baylor, Houston.

Dr. Clifford Hudis had a segment, and if you can find this session on line, it will show how the oncology community is thinking. I sure wish they had more PUSH/PULL with the FDA.

(Perhaps this talk can be found under Rhondalea's downloads at the top of this forum.)

[phil]

Happy New Year to all you Fighters ! There was much more awareness of Stage IV Rights in 2012; there will be more Progress in 2013 ! I am still alitle groggy from last night , but I went thru the FDA opinion quickly. Chrisy , This FDA post 2009 deserves all the suspicion , skepticism. I can't say this article raises clear alarms, but watch out. There has been nochange at the top, just a circling of the wagons. Dr.s Hamburg, Pazdur and Woodcock know their mis-handling of T DM-1 will be scrutinized, so we anticipate a PR campaign , playing up its risks, black box warnings etc. Why have they taken over 4 months of the priority review time , for this drug they know so well ??
Not sure if this article is part of that, but... they do not have a mechanism for Stage IV in-put. They label you as " desperate " ( we have 3 form ltr e-mails to prove it ) . We hope to have publicity for our cause thru t dm-1 , then legislate stage iv involvement at the highest FDA decision-making level. Help us by contacting media; we didnt know anyone when we strted but friends, family did. we got pretty good Boston coverage, hope for nat'l soon .
Lizbeth, join OurHer2cancer struggle on facebook , link thru my fb , philip mccartin. we have big plans for 2013 many blessings , healing to youall in 2013 !!

[StephN]

Big plans, Indeed! Phil.

Just posted two more T-PAS, D-DM1 sites today. That makes a total of 20 and they are pretty well spread around the country now.

I think this is all groundwork for the approval by getting more treatment centers on board and up to speed.

[chrisy]

Steph, that makes a lot of sense, get people ready to hit the ground running upon approval.

[phil]

We are looking for t dm-1 responders , 6 months plus , for a possible nat'l story . e-mail me at pmccartinjr@comcast.net , w/ brief bio, and the story of your battle w/ bc.

[phil]

I guesstimate that less than 2,000 Stage IV Survivors have been able to try T DM-1 in the US in almost seven years of testing . Isn't that pathetic ? A drug that has the best survival stats ever for her2, that will " revolutionize " her2 tx . ? We knew this in 2010. We were ignored . Our thanks to those who are willing to Speak Up . e-mail us your t dm-1 stories to pmccartinjr@comcast.net. This FDA System let too many die over the past 2 yrs. Never Again !

[phil]

Time for another Stage IV Rights Protest ! Guess who is the Featured Speaker at this yrs Mass BIO Annual Mtg . ? The FDA Commissioner , Dr. Margaret Hamburg ! So all who missed last yrs protests, come join us on the " Front Line " ! To change This FDA " System " , to give us a voice in the drug approval process, quicker access to save more lives, informed choice , flexible treatment, March 14th, 15th, Royal Sonesta Hotel, Cambridge , Mass. Details to follow

[phil]

we would like some of your wise feedback. we feel T DM-1 approval should cover all who are stage iv , strongly Her2 +, at dx. and all who progress on a herceptin based therapy . to spare pts from taxanes, tykerb / xeloda.
What do you think ? we doubt This FDA will be so generous, and we are gearing up for another Protest , if appr. is too restricted. Thanks.

[chrisy]

Phil, didn't the early phase 1 or 2 studies show high response levels with an average of 7 prior therapies, range was like 3 - 12? I am speaking off the top if my head so I'm sure I'm off a bit, but the point is it has shown efficacy in heavily pretreated patients. I also would favor seeing earlier stage not having to go through chemo but think that's unlikely to happen without trials as a single agent.

[Nancy L]

Would be great to have 60 Minutes expose the FDA and how clinical trials really work. They are friendly to the Obama administration so they might not be interesting in exposing Kathleen Sibelius.

I would be interested Phil in how many 6 month T-DM1 success stories you have heard from so far. I have been disappointed in how many on this site have not had success with this drug.

[phil]

right you are chrisy, many prior toxic therapies that you, Lorraine and others here are very familiar with. None of the top FDA officials are familiar with them in any real sense. thats the problem. the researchers say it will ' revolutionize " the tx of her2 , but This FDA will hold it back, and thousands more will die. when will perjeta ever get to stage iv pts ? when will t dm-1 ever get to people like Lorraine was in 2006, with one visible tumor, not 7. she was lucky to have it go only to liver area, and to get aggressive , state of the art tx to stay alive. Stephn, i have heard from many who have yrs , 1, 2, 3 and 4 yrs. many who get good results in trials don't know how lucky they are. and there are so few when you crunch the numbers. for ex., we ran into a pt when we started in va., over ayr ned , she didnt know anything about t dm-1. she lived down the road , and her doc sent her to the clinic. the current trial system is slow, and small no's . my estimate is probably Gen. has given t dm-1 to less than 2,000 pts total , and with a 60% or so success rate , thats about 1,000 , many of them new, getting it only in past yr in expanded EMILIA, THERESA. when we were trying to get it in 2010, 3 + yrs into trials, there was only one trial at Farber, and it took a new pt once very month or so. pathetic. overall t dm-1 enrollment is a pathetically low no. for over 6 yrs of testing. but typical of trials in US. in the 6th decade of the " war " on cancer. in the 21st century . yet 240,000 will be dx this yr, 40,000 will die . got to get it to the early stage folks. got to keep Protesting . its past time to " Fix This FDA "