TDM1 EAP -Good news for those in TDM1 EAP who need to travel

[phil]

Genentech has asked the FDA to approve an " amendment to the Access protocol ". Allowing pts who are enrolled, and responding to the drug, to petition to switch the tx to a hospital/clinic closer to home. So, we could get it in Boston. And others closer to their homes. Time frame : before the end of Aug. Maybe sooner.
Whats really important, if you want the drug, you could travel to the nearest access site, enroll, get 3-4 doses, get cts, and if its working, switch to a closer hosp./clinic. That would mean traveling for about 3 months. Once every 3 weeks.
We remain big on this drug. W/ heavily pre-treated pts like L. , the drug does knock down platelets. But it also knocks the crap out of her2 cancer. L. had to go 7 weeks w/o it, due to sepsis ( un-related to t dm-1 , a stent from last yrs " collateral dmage, taxanes, adria etc. ). Even w/ a reduced dose , after 7 weeks W?O ANY DRUG, her counts are great ( except plats ). Good energy, full head of hair, no chemo brain ( that ones L. reading over my shoulder). We hope to get as much of the drug as plats allow until approval. You know I am on the FDA's case , every week. Now that Gen. is being more flexible, our full attention should be on this FDA Administration. Dont forget, we wouldnt be having this struggle if they had approved it last yr.
L. and I hope to be in DC next week, to support the Avastin survivors. All of you w/in 2-3 hrs travel time of the FDA should be there too.Watch, and learn as the FDA tries to stone-wall them. I've told them , tell your stories . They are powerful, to the press , thus to the people. No matter what the FDA decides about Avastin next Tues,. IT AINT OVER ! Until their way of doing " business " is changed.