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Old 05-29-2011, 08:48 AM   #1
chrisy
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Join Date: Sep 2005
Location: Central Coast, CA
Posts: 3,207
Exclamation 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
__________________
Chris in Scotts Valley
June 2002 extensive hi grade DCIS (pre-cancer-stage 0, clean sentinal node) Mastectomy/implant - no chemo, rads. "cured?"
9/2004 Diag: Stage IV extensive liver mets (!) ER/PR- Her2+++
10/04-3/05 Weekly Taxol/Carboplatin/Herceptin , complete response!
04/05 - 4/07 Herception every 3 wks, Continue NED
04/07 - recurrence to liver - 2 spots, starting tykerb/avastin trial
06/07 8/07 10/07 Scans show stable, continue on Tykerb/Avastin
01/08 Progression in liver
02/08 Begin (TDM1) trial
08/08 NED! It's Working! Continue on TDM1
02/09 Continue NED
02/10 Continue NED. 5/10 9/10 Scans NED 10/10 Scans NED
12/10 Scans not clear....4/11 Scans suggest progression 6/11 progression confirmed in liver
07/11 - 11/11 Herceptin/Xeloda -not working:(
12/11 Begin MM302 Phase I trial - bust:(
03/12 3rd times the charm? AKT trial

5/12 Scan shows reduction! 7/12 More reduction!!!!
8/12 Whoops...progression...trying for Perjeta/Herceptin (plus some more nasty chemo!)
9/12 Start Perjeta/Herceptin, chemo on hold due to infection/wound in leg, added on cycle 2 &3
11/12 Poops! progression in liver, Stop Perjeta/Taxo/Herc
11/12 Navelbine/Herce[ptin - try for a 3 cycles, no go.
2/13 Gemzar/Carbo/Herceptin - no go.
3/13 TACE procedure
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