TDM-1 petition to Dr. Kathleen Sebelius, Secretary of Health and Huma

[dchips1]

I am subscribed to this petition site. they are looking for more people to sign up to try to Get approval prior to 2013.


After giving us the runaround for months, Sec. Sebelius ' Office finally got back to us about a meeting to discuss Our Petition. They said NO ! They do not wish to " escalate this issue further ". Escalate ? They have done nothing ! We told them that this decision to deny us a meeting reflects poorly on Secretary Sebelius and her office. Ignoring 7,000 Citizens requesting a hearing to discuss this life and death issue. This FDAs' denial of Herceptin T DM-1 to Stage IV Cancer Patients, for the past 2 years ! E-mail seth.h.wainer@hhs.gov and christie.hager@hhs.gov and keri.kohler@hhs.gov Tell them how you feel ! Give us the Hearing we deserve ! Pass on the Petition !

http://signon.org/sign/fda-blocks-life-saving?source=s.em.cr&r_by=1150228&mailing_id=3872


Darita

[KDR]

Phil, what can do as a collective here? To move past the petition level and get an across-the-table meeting with Sebelius?

A tiger this morning,
Karen

[phil]

First sign and pass on the Petition. Then bombard the HHS officials listed above . We at Our Her2 Cancer Struggle plan to Rally on Monday, June 18th at the International Biotech Convention, in Boston. Any close by are welcome to attend, speak up. More details to follow. Another of our mbrs who has been waiting for t dm-1 finally got it, first scan shows good response after just 3 doses at 3.6 . Needed that up-lifting news this week. This crazy FDA has been allowed to wreak havoc with the approval process. Now I hear rumors that pertuzumab may be approved only for first re-occurences , or some thing like that ? Are they CRAZY ?? That cannot stand ! We need media attention to Publically Shame them ! I think all it will take is about 200 of us in our pink Fix The FDA shirts, w/ signs , at that Convention. You've seen our video on youtube, the only thing we missed was the media. Now we go where they are . Details to follow in the next few weeks.

[karen z]

Thanks for posting and letting us know about the petition.
karen

[Rich66]

Im assuming the usual suspects (AM cancer association, Komen etc) have been alerted. But this one might be helpful somehow: http://www.noreenfraserfoundation.org/

(By the way..doesn't look like Sebellius has any medical education, much less MD...nor PhD.)

[phil]

Maybe someone more techie than me , can post this on other sites.
Sec. sebelius is not a doctor, our mistake. We had that on signs at our rally in Dec. At the end of the Rally , Lorrraine, myself, and Ann , a Survivor wanting t dm-1, her mother, took a paper copy of the pet. across the Plaza to the federal bldg. We walked in, ( had called first, as signon.org had recommended ) , and sta down w/ an asst. regional HHs official. She tols us , dryly, " Shes not a Doctor ". Oh well, to be honest , sadly, if she was a doc , it wouldnt have made adifference. At the higher levels of Govt, Big Business, they leave thier hippocratic oath at home. Big research is silen too, afraid of blackballing .
The enrgy at the Rally was awesome. gets me excited about June 18th. My favorite memory of the Rally was the 4 speaker Survivors , and helen, another bc survivor, meeting , most for the first time) , talking , laughing in the van before the Rally. it was adrizzly day , like today , but it was definitely warm in that van... Myself and the other Caregivers sat back and watched, Come join us in June... you'll see...we cant be stopped, we have conquered so much already !

[phil]

Maybe Noreen , and her foundation will help, she understands Stage IV issues . The otherrs , Komen, ACS, NBCC, dont get it. Cant even find a decision -making person in ACS to talk w/ NBCC never returned my calls, e-mails last yr., and decided to play scientist w/ Avastin. Komen said , " We dont endorse a particular drug ". Its about supporting the Survivors. We know you're not scientists ! You are supposed to advocate for us .

[Rich66]

It might be good to have a compelling main contact person for press etc to deal with. I'm thinking an articulate patient who benefitted in previous trials.

[jellybean]

One thought. . . . The results of a recent big trial (EMILIA, I think) with T-DM1 are scheduled to be presented in a plenary session at ASCO, which is the first week of June. This suggests to me that the results will be very favorable. You might want to wait a few weeks to scale up your demonstrations, so you (hopefully) will have great data from this presentation to use.

[jellybean]

From a healthcare business posting:

T-DM1 (Trastuzumab emtansine, Genentech/Roche) in HER2+ Breast Cancer
The concept behind T-DM1 is exciting – adding the benefit of chemotherapy to the specificity of targeted therapy, thereby decreasing normal chemotherapy-associated toxicities – which could lead to treatment paradigm changes if successful. Currently, three Phase 3 trials are examining the efficacy and safety of T-DM1 in first-line (MARIANNE), second-line (EMILIA), and third line (TH3RESA), of which EMILIA is expected to support initial launch. In March 2012, Genentech announced top-line results from the EMILIA trial, indicating improved PFS in patients treated with T-DM1 compared with those treated with Tykerb [lapatinib; GlaxoSmithKline] plus Xeloda [capecitabine; Roche] in 991 HER2+ breast cancer patients who had previously received treatment with Herceptin and a taxane.
Last years’ FDA revocation of Avastin’s approval in breast cancer has raised awareness about the need for meaningful PFS or OS benefits in this disease. With this in mind, all eyes are going to be on the magnitude of PFS benefit produced in EMILIA, especially considering that any overall survival (OS) data presented at ASCO will be immature. [B]EMILIA, Abstract LBA1, Sunday June 3, 1:45pm, Plenary

[sarah]

good info. signed on. TDM-1 is supposed to be a miracle drug - let's hope so, we need it!
health and happiness
sarah

[Rich66]

http://www.xconomy.com/national/2012/05/14/asco-preview-eight-cancer-drugs-to-watch-at-the-big-show/


Partly because this drug is working against a high-profile disease like breast cancer, and partly because of its groundbreaking science as a sort of anti-cancer smart bomb, I’d bet that this drug will be the star of the show at this year’s ASCO. The presentation also happens to be timed for the deadlines of the nation’s major Sunday newspapers. Watch for the headlines on June 3.

[schoolteacher]

Hope it is approved this year.

Amelia

[schoonder]

A new EORTC sponsored trial which includes t-dm1 is soon to get underway.

http://www.clinicaltrials.gov/ct2/show/NCT01597414?term=01597414&rank=1