Meeting Up in San Antonio NEXT WEEK!

[phil]

P.S. , maybe they will approve it after 5 EST tonight. Duck Big Media Publicity, yet still be " the talk " of the Symposium ! If so, don't let em get away w/ it !

[Paula O]

Sorry, I don't understand the P.S. What does it mean?

For anybody whose going,

Here is a link to the 10 day weather forcast to help with packing: http://www.weather.com/weather/tenda...+USTX1200:1:US

See ya soon,

Paula

[phil]

sorry for confusion. I meant that noone knows when This FDA will approve t dm-1. their hx since 2009 is to issue approval notices about " controversial " drugs late on Fridays. that way they keep it out of the news.
looks like it wont be appr by time of Symposium, so it will be bizarre ; people talking about trial design , the wonderful stats , etc. of a drug that almost noone can get ! Imagine how many " Lorraines could be saved between now and Christmas ...many...

[StephN]

Paula -
The HER2group is here near the convention center. We will be setting up the booth at 1pm then heading to the educational sessions. Maybe you can catch us at the booth, before joining a herd of people in the ballrooms for the presentations.
They may not let you in the exhibit area without an Exhibitor ribbon on your badge, but maybe you can find a way to the back of that area near where the sign says "Exhibitor Services."
We are next that area.

[Rolepaul]

Ask the Genentech folks about supporting the MD Anderson work for Intrathecal Herceptin for Leptomeningeal and spinal nerve involvement by HER+ disease. Also, can someone get contacts for the Poster5 session 16 and 18 posters so I can write for copies. Lastly, if anyone sits in on the session Winer is moderating and hears interesting news, please let me know. Bummer not be there, but I used all my vacation time to see Nina when she was in Houston and now to go to MRI scans and doctor visits. Maybe next year.

[StephN]

Hello Rolepaul -
Do you want ALL the posters from Session 5, groups 16 & 18?

Group 16 (Immunotherapy) has 6 posters.

Group 18 (HER2 targeted therapy) has 26 posters.

I can get some reprints for you if you can find which ones you specifically want.

[Soccermom]

Looing forward to updates y'all. Wish I were there with you

Marcia

[Rolepaul]

I was able to get abstracts through Nguyen and will be contacting the lead authors. These are really good seesions. I am jealous.

[phil]

Ask docs there , do they think T DM-1 will be approved for all who progress on original herceptin , or will folks have to go thru taxane / tyk /xel nasty s/e ?
T DM-1 could be a nice " Christmas present " from This FDA . About time .

[StephN]

I have heard mention of setting up trials for Adjuvent T-DM1, but nothing yet from Genentech.
Our group will be at the Gen. Advocates Briefing tomorrow night, and we will get all the scoop direct from them as well as asking questions if they do not address this.

[Paula O]

My brain is busting at the seams with information (not that I understand it all, that's for sure)! It was an excellent symposium.

Welp, Phil-- I spoke with some oncologists, breast cancer advocates, Gennentec reps, and sought out some media folks about the FDA's denial of TDM-1's accelerated approval. The two words I heard most often in response were "Due Diligence". Many people expect TDM-1 will be approved in early 2013, probably in February, and feel confident that it will be approved once the FDA has done it's job fully examining safety and efficacy. After a special meeting of breast cancer advocates with Debbie L and a research oncologist (Dr Sara--forget her last name? Horwitz? presenting on Tdm-1 (Project Lead Advanced Topics for advocates and those a part of the Alamo Breast Cancer Foundation ) I stood up and shared frustration over the delay while many Her2 positive patients were experiencing disease progression and death and not able to access a drug which has strong proof already that it is safe and effective. Honestly, it was rather embarrassing to me that I got choked up and started to cry at the end of delivering my passionate little speech to the group (a summation of what you shared here) about those in urgent need of early approval of TDM-1 but I guess people got the message that these are real women in tough straits right now waiting for approval, some of them dying without the drug after exhausting other available options.

Phil, I am going to PM you contact info for one of the media people I spoke with briefly (a Chief Honcho assistant director at the symposium ) if you want to tell him Lorraine's story.

Paula

[phil]

We so appreciate your Speaking Up ! You and the others who spoke up , wore the shirts sent a message : We are Speaking Up for Stage IV Rights !
I didn't expect you to get much response from the docs, pharma reps , or " Big Advocacy ' It was worth a small gamble , sending shirts, flyers . Hoping for an investigative type reporter to pick up the story . That may still come when approval comes. but maybe not , so we will have to Protest ! If i had been able to get to San Antonio , I would have been protesting outside, just like in Boston this past yr., protesting that these Big Entities ( FDA, Big Advocacy, Docs who wont speak ( will get black listed ) just don't get it , that this FDA\ Big Pharma - led cancer drug approval System actually exploits Stage IV Survivors . And is not keeping up w/ 21st century advances like t dm-1, pert., drugs w/ fewer s/e. So , again , thanks for speaking up , T DM-1 is so good ( not perfect ) , that it will lead the way in exposing the failures of This FDA System.

[StephN]

Phil - There is another piece from the treating side. LAW SUITS. Malpractice insurance is quite costly, and doctors carry it as anyone who has a bad reaction to just about any drug can go to a law firm (they advertise on TV all the time) who says they will represent a patient who got a Bad Drug.

Research and trials do not necessarily guarantee safety for every patient. I do not know the extent that the 'sue me - sue you back' society we live in influences the FDA decisions, but they have some very specific rules to follow.

Patient safety has notched up, as a concern. Also, there are dozens of drugs for other cancers and conditions that are on the FDA docket.

I did speak to someone who has worked with the FDA for many years, who is well aware of the need to get T-DM1 to market. This person told me that Genentech took a "long shot" in designing a Single Arm Trial and applying for approval on the basis of those results. You well know that the FDA kicked that application back and asked for data on a broader basis with comparative data on other standard of care drugs.

[phil]

Stephanie, thanks again for your efforts. I disagree , of course , with all the naysayers , most of whom dont know the drug. it is an exceptional drug, and the stats showed it in 2010, over 3 years of testing, completed Phase I, II trials for safety, dosing . and results . As I see it, only 3 groups really know the drug, 1.the patients who have seen Stage IV tumors melt away, 2. the top research docs , including Dr. Winer , who have stated that it should have been approved 2 yrs ago, and 3. the Genentech /Immunogen clinical teams , who developed and studied the drug. I have been to This FDA, they did have a pre-conceived bias; I have been to Capitol Hill, have seen one Party covering up for its own at the top of the FDA .
So take comments from rival pharma execs who dont know the drug, , docs who cant speak up for fear of FDA backlash ( same risk for Gen. execs ) , with a big grain of salt. And media who run from ' big name personalities " to personalities ", from fluffy story to fluffy story tonight at 6, . You see how they half-listen to you , who are you ? what degree comes after your name, who do you work for ? what have you done ? Are you a lobbyist , w/ connections ? No , " jst ' someone who SURVIVED Stage IV for YEARS, thats all !! , so the drug with " best ever so far survival statistics ' for her2 , the one that will " revolutionize ' tx of metastatic Her2 , should have taken nearly 7 years to approve ? I just can't accept a System like that , it wasnt " risk " , or " due diligence ", it was This FDA flexing its regulatory muscles with Big Pharma, punishing them for past ' errors ', Big Brother FDA pushing longer stats called Overall Survival ", deciding for you what risks/ benefits should apply , . There are now other tdm-1-like conjugates in Phase I trials, for other cancers , will they take 7 years to get to us ??

[StephN]

Phil -

Paula, that was a heartfelt and honest appeal. BRAVO!

I certainly agree that T-DM1 should have had approval. If someone in the FDA decided the agency made a mistake in approving the single arm trial, then THEY should live with that. But then other drugs will come to them with single arm trials, and some of those may not be as good as our special drug conjugate.

The person who I spoke with has a long and deep abiding interest in metastatic breast cancer. She was at the FIRST San Antonio symposium, and goes to other meetings as well. From what I could gather, patient advocacy IS our best route at this time, and you are right that we need more people to speak up.

I did hear several "thought leader" type doctors speak from various podiums during the conference on the "fog of trials" which they think should have better designs and clearer effective parameters. The frustration with slow acceleration in getting good drugs to human trials and beyond is spoken more freely each year I attend the conference.