TMD1 is coming!

[Pray]

Nancy, I'm so sorry you were denied! Gods blessings to you. I will keep you in my prayers.

[Nancy L]

Phil,

I asked the trial coordinator and onc if they would help me make a case for expanded access. They said once the rules are announced, they will let me know if they think I could qualify but they didn't sound encouraging. I'll keep you all posted if I learn anything useful about how expanded access will work this time around.

[KsGal]

Im so sorry Nancy. ((hugs)) I know we are all excited about the possibility of TDM1 being approved on a fast track. I still worry. I was excited about Pertuzimab as well, and then when it was approved, its not for people who are stage IV like me. Im really happy for those who are able to receive it, but Im a bit selfish and I would like to share in all these cutting edge drugs for myself as well. Here's to hoping we will all be TDM1 eligible when it is approved.

[Ellie F]

Sorry to hear this news. Hope and pray itwillbe available for all soon
Ellie

[phil]

Nancy, while they "debate " possible exp access exclusions , what about applying for comp. use ? you can tell how ticked off , to put it mildly, that we are w/ all the bureaucracies stumbling , bumbling over such a miraculous drug ! One of our activism " planks " will be Flexible Treatment for Late Stage IV Pts , shorter washouts, keeping folks in trials even w/ " mixed response ", and for the pharma co's : If you think your drug is good enough to be considered for acc. approval, its good enough for comp use to late stage iv pts. If FDA rejects acc. appr., you finish the phase III trials that they want. Hopefully in the future we will have a 21st century FDA that can help get trials in that category to be reviewed more quickly, not 2 + yrs like This FDA with T DM-1.

[Nancy L]

Phil, I had radiation to reduce the pain caused by the tumor pressing on the bronchial plexus. They told me the radiation would not eliminate the tumor. The problem is the way they write the inclusion criteria. You must have regressed on your most recent protocol, which for me they say is radiation, not tykerb. The trial coordinator for Th3resa said the tumor would have to start growing again to qualify for expanded access. But my husband is going to call either Genentech or Stockton tomorrow morning and plead my case.

I am curious---if the FDA is going to fast track and approve this year, why would Genentech set up EAP for just a couple of months???? I could understand doing so if it was available at all trial sites. But having only three makes access very difficult for most women. I didn't realize how screwed up the FDA is untill I got involved trying to participate in a clinical trial.

[hutchibk]

That's a question for them when your husband calls, for your clin trial coordinator, or for Sonali at Genentech.

[phil]

This Adminisration has un-leashed some FDA bureaucrats, who are hell -bent on "dotting every ' bureaucratic ' i ", punishing co's for some not finishing trials after acc. appr was granted yrs ago. So they revoke avastin, reject acc apr for tdm-1, partial apr for pert. FDA Press releases on Friday nights to avoid publicity. Bureucrats who were angry that gen. appealed revocation of avastin. Bureucrats who dozed off during avastin super -repsonders testimony. Note that all are Genentech drugs. So the co. is under the gun with This FDA. Who knows when t dm-1 aaproval comes ? and whether there will be conditions. could be Nov., dec. ? march ? gen has done the trials, so exp access gets it to some pts, is agood pr move. remember thye pay for the drug in access. I havent called Gen., to ask how many exp. access sites are open ?

[hutchibk]

I would call Genentech/Roche, they will know locations. Yes this FDA has "it out" for the pharma company... you know how I feel about this FDA. Possibly TDM1 approval mid-Feb. Just one girl's opinion.