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

Just received this information from the Patient Advocate at Genentech. They are working to amend the protocol for the EAP (T-PAS) to allow SOME of the actual treatments to be adminstered locally. They are still not opening any new study sites...but those who, say live in Boston and would have to travel to Fairfax (or in Seattle traveling to So Cal or in Austin going to Denver) may have an option, once they are established in the trial, to get some infusions locally. This is still probably a few months away to get the amendment done and approved.

Still not as good a FDA approval of the drug...but may provide some relief in the interim...

The message she sent me is below:

Genentech has been contacted by multiple patients requesting T-DM1 from their local oncologist as part of T-PAS or seeking individual access. We know that many people have to travel long distances, and we recognize this significant burden, especially considering their advanced cancer. We are trying to do the right thing for patients while ensuring we are being fair, and also not impacting the clinical trials we need to conduct in order to get the medicine approved. Therefore, we are planning to amend the T-PAS protocol, allowing people who are enrolled in the trial and responding to T-DM1 to receive some T-DM1 doses locally. Additional details of the protocol amendment are not yet final, but we are working as quickly as possible and hope to have the amendment in place within 90 days. Our primary goal remains getting T-DM1 approved so access is not an issue for patients.
While we understand it can be difficult and costly to travel long distances, our hope is the amendment alleviates some of the burden by allowing some doses to be administered by a local oncologist. While we are working to get the amendment approved, we recommend people who continue to face travel challenges to contact an organization that may be able to provide travel assistance:


· Air Care Alliance, www.aircareall.org, 888-260-9707
· Air Charity Network, www.aircharitynetwork.org, 877-621-7177
· Airlines of the Web Medical Air Services, www.flyaow.com/airmed.htm
· American Cancer Society (Road to Recovery), www.cancer.org, 800-ACS-2345
· Angel Flight Central, www.angelflightcentral.org, 866-569-9464
· Angel Flight for Cancer Patients, www.angelflightforcancerpatients.org, 800-296-1217
· AVONCares Program, www.cancercare.org, 800-813-HOPE
· CancerCare, www.cancercare.org, 800-813-HOPE
· Chai Lifeline, www.chailifeline.org
· Corporate Angel Network, www.corpangelnetwork.org, 866-328-1313
· Hospitality Homes, www.hosp.org, 888-595-4678
· Joe’s House, www.joeshouse.org, 877-JOESHOU
· Lazarex Cancer Foundation, www.lazarex.org/lookingforhelp.html
· Lifeline Pilots, www.lifelinepilots.org, 800-822-7972
· National Patient Travel Helpline, www.PatientTravel.org, 800-296-1217

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

At least that's a start and I'm sure that will help some of the ladies that are traveling so far. I know Genentech has received alot of calls about how difficult, or should I say near impossible for many of us ladies to get to these EAP sites. I've personally made serveral calls myself over this one issue. The financial aspect of it's a deal breaker for so many.

I still hate to hear it will be another 3 months or so. That's a long time in a stage IV's world with all the appts we have...along with the fatigue and all that comes with it. But it is nice to see they are working on it. I am sure Genentech has been inundated with calls about T-DM1 and all the issues surrounding it. I just wish the FDA would give it's final approval and be done with this. Thanks for sharing this news with us Chris....surely appreciate it.

Chelee

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

If anyone has been following Lorraine and Phil McCartin's journey, it's apparent the toll traveling takes, especially via plane and having an overnight stay. I saw on their Facebook page yesterday that Genentech will now allow Lorraine to receive her treatment at home in Boston, beginning in a few weeks. For those who don't know, Phil McCartin has been a huge (political and local) advocate in getting T-DM1 to people who need it most.
Hurray, Lorraine!
Karen

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

Great news, Chrisy! Thanks for sharing. I am participating in a T-DM1 trial in Charleston, SC, traveling from Atlanta. The trial is going well for me. I just found out on Friday, after 9 weeks on the trial, that the T-DM1 is working! My tumors have either shrunken or remained stable. I had not anticipated when I signed on for the trial how difficult the traveling would be. It is the worst part of the experience for me, so your news is very welcome. Thanks! Ann

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

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.

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

Great information on this thread... Just bumping it to make it more accessible...!
Marcia

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

Went to DC last wk. Got dose # 9. Latest Ct, counts look great. Still hearing that we will be able to transfer tx. to Boston in about a month. Access will close Sept. 6th. Have heard of at least more women from NYC who have enrolled out of state, Va. Mich. Because the access is closing.
After Sept. 6th, there will only be trials, w/ extra requirements, 30 day wash-out vs. only 2 weeks for access. Closing of access is due to this FDA 's obstinate refusal to see whats right in front of their eyes. No respect for Stage IV Survivors, no compassion. They have decided to make you guinea pigs for thier new , more rigid regs. " Overall Survival " stas. harder to prove, and definitely morally wrong w/ this drug. Until this FDA's ruling on T DM-1 is investigated, overturned. Only way is to bring it to the Publics attention, again, and again. All of you on taxanes, tyk/xel., this FDA is extending your suffering . Denying you a low s/e , even better drug. Call your Congr. Reps. have they called the FDa ? Their own HELP Committee ? Asked Dr. Sebelius in HHS to investigate ?
If you are metastatic Her2 , this drug has to be checked out. If you are suffering w/ s/e of tyk./xel. , and have already progressed on taxanes. You may qualify based on intolerance of tyk./xel. You need an assertive doc, to help you argue your case. All docs tend to be conservative, its in their training. Even the nice ones, you need to give them a push. And they are all busy, what? 18 pts a day ?

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

Want to make sure that all of you traveling to get t dm-1 know that the FDA has now allowed transfer to a site closer to your home. Our clinic in Va. has already begun the paperwork process. Transferring to the Farber in Boston, YAY !!! Push your site to get the process started. They are very busy, so always speak up ! Heres to no more expensive, stressful trips ! ( nevermind needless, Thanks FDA ! ).