T DM-1 Activism - Page 2

phil · 02-20-2013, 12:02 PM

Approval of some type is any day now. Our thanks to those who have shared their T DM-1 success stories with us , we have a few willing to go public up here in Boston. we need more. even if you have just had 3 months, passed first set of scans , you should tell your story to media. look for local reporters who have covered breast cancer recently. e-mail them today . tell them this revolutionary drug will be approved ,somewhat, this week. tell them the " real story " about the " smart bomb ' drug , that it could have been available over 2 yrs ago, that This FDA was biased, wanted to push more stats on overall survival and had dispute going w/ Genentech over Avastin. So they ignored all top bc oncologists recommendations, Farber, Sloan , MD Anderson et al, and rejected T DM-1 for early approval. tell them we stage iv survivors want This FDA 's delay of T DM-1 investigated ! Their biased decision cost hundreds , even thousands , of lives ! including our friends ... and how This FDA then took 6 long months to analyze final data, no urgency because they know they will look bad, and noone in DC has oversight of them . This FDA will play up side -effects, and has labeled Lorraine and other early responders as " outliers " , unusual. They were not ! 38 % of Phase II trial participants had the same response as Lorraine way back in 2010 , that is a great statistical response. Don't let This FDA get away with it ! or it will happen to the next life-saving drug.

phil · 03-12-2013, 05:46 PM

This FDA Commissioner, Dr. Hamburg , is coming to Cambridge this Friday , March 15th. To address the Mass Biotech Council. She probably will talk about the " New " drug , " kadcyla " she " just " approved. We will be there, Our Her2Cancer Struggle , to tell the Real Story about This Slower than Ever FDA . Come join us, 9:30 -12:30 , Royal Sonesta Hotel, Land Blvd., Cambridge.

schoonder · 03-22-2013, 01:25 PM

Recently NIH has added T-DM1/Pertuzumab as drug combo to I-SPY2 program.

http://www.clinicaltrials.gov/ct2/sh...2+t-dm1&rank=1

http://ispy2.org/wp-content/uploads/...t_Brochure.pdf

Mandamoo · 03-22-2013, 05:25 PM

Glad to see Perjeta being added here - there are those of us who remain Herceptin resistant and had little benefit from kadcycla which may find addition of perjeta beneficial - will be good to see results.

phil · 04-01-2013, 12:43 PM

Saw a news story on FB last week , about the " first " pt. to get the " new " drug , kadcyla ( TDM-1). NBC ch 4 in LA. One dose and she is released from Hospice. While I am very happy for her, the superficial news coverage of T DM-1 is sad. This is NOT A NEW drug !
This partial approval should have happened THREE YRS AGO ! How many others could have been discharged from hospice...we could have already run a trial to compare it to taxanes, and we knew in 2010 that it has fewer side -effects... when will This FDA /BIG PHARMA System allow T DM-1 to be combined with other drugs ? When will THEY give Perjeta to all HER2 Stage IV Survivors ?? When will Stage IV Survivors have DIRECT INVOLVEMENT in the cancer drug approval process ?

KDR · 04-01-2013, 04:16 PM

Phil
As we have discussed, I too believe Perjeta is the key in combination with T-DM1, and I think there is enough data to support that with the conclusion of the trials.

Is it possible to approach John Kerry on the topic?

Karen

phil · 04-02-2013, 08:19 AM

Kerry's people were helpful in beginning for our personal issues, 2010- 2011 . spoke w/ Co. and FDA , brought us to HELP at time. Sen. Harkins staff. It died there . We asked Sen Kerrys' staff 3 times for a face to face mtg, told he was too busy. he is now Sec. of State , so now truly involved with global issues.
We are trying to contact his successor, Sen. Elizabeth Warren . Perhaps she and other women in Congress will be more pro-active with This FDA than the men . Sen Kay Hagan from NC has seemed to want to reform FDA drug appr. process.
Google the US Congress , HELP Committee. If u see any names there that represent you, call their office, meet . You , as a Perjeta / TDM-1 success story, can have a role in pushing the FDA and co. to give perjeta appr. to Stage IV sooner . at this rate , when will it be fully appr. ? this yr at all ? always use Lorraine as a T DM-1 example too, ( we know others even longer ned than her ) , we will talk with anyone , anytime.
The LA news story can be found at www.nbclosangeles.com, " New Breast Cancer Drug Gets Woman Off Her Death Bed "