|
06-27-2011, 03:03 PM
|
#1
|
Senior Member
Join Date: Jun 2011
Posts: 107
|
Genentech/ TDM-1 info for making your voice heard
Rep at Genentech told me today that they are documenting all calls that come in regarding women asking to get access to TDM-1. Currently there are only 12 states that offer this drug through Genentech's expanded access program. Genentech is currently working on a protocol amendment that would make TDM-1 avaliable in more states.
Please make your voices heard. Ask that Genetech make this drug avaliable for compasionate use. Ask that women in all states would have this drug avaliable to them.
GENENTECH 1-888-662-6728
Thank you!
|
|
|
06-27-2011, 07:40 PM
|
#2
|
Senior Member
Join Date: Oct 2005
Posts: 3,519
|
Re: Genentech/ TDM-1 info for making your voice heard
I don't know for sure what the Rep meant, but Expanded Access Protocol (EAP) IS the same as compassionate use...
Here's a thread about what Genentech has already shared with us about this situation and the idea that they are tossing around...
http://her2support.org/vbulletin/showthread.php?t=50196
__________________
Brenda
NOV 2012 - 9 yr anniversary
JULY 2012 - 7 yr anniversary stage IV (of 50...)
Nov'03~ dX stage 2B
Dec'03~ Rt side mastectomy, Her2+, ER/PR+, 10 nodes out, one node positive
Jan'04~ Taxotere/Adria/Cytoxan x 6, NED, no Rads, Tamox. 1 year, Arimadex 3 mo., NED 14 mo.
Sept'05~ micro mets lungs/chest nodes/underarm node, Switched to Aromasin, T/C/H x 7, NED 6 months - Herceptin only
Aug'06~ micro mets chest nodes, & bone spot @ C3 neck, Added Taxol to Herceptin
Feb'07~ Genetic testing, BRCA 1&2 neg
Apr'07~ MRI - two 9mm brain mets & 5 punctates, new left chest met, & small increase of bone spot C3 neck, Stopped Aromasin
May'07~ Started Tykerb/Xeloda, no WBR for now
June'07~ MRI - stable brain mets, no new mets, 9mm spots less enhanced, CA15.3 down 45.5 to 9.3 in 10 wks, Ty/Xel working magic!
Aug'07~ MRI - brain mets shrunk half, NO NEW BRAIN METS!!, TMs stable @ 9.2
Oct'07~ PET/CT & MRI show NED
Apr'08~ scans still show NED in the head, small bone spot on right iliac crest (rear pelvic bone)
Sept'08~ MRI shows activity in brain mets, completed 5 fractions/5 consecutive days of IMRT to zap the pesky buggers
Oct'08~ dropped Xeloda, switched to tri-weekly Herceptin in combo with Tykerb, extend to tri-monthly Zometa infusion
Dec'08~ Brain MRI- 4 spots reduced to punctate size, large spot shrunk by 3mm, CT of torso clear/pelvis spot stable
June'09~ new 3-4mm left cerrebellar spot zapped with IMRT targeted rads
Sept'09~ new 6mm & 1 cm spots in pituitary/optic chiasm area. Rx= 25 days of 3D conformal fractionated targeted IMRT to the tumors.
Oct'09~ 25 days of low dose 3D conformal fractionated targeted IMRT to the bone mets spot on rt. iliac crest that have been watching for 2 years. Added daily Aromasin back into treatment regimen.
Apr'10~ Brain MRI clear! But, see new small spot on adrenal gland. Change from Aromasin back to Tamoxifen.
June'10~ Tumor markers (CA15.3) dropped from 37 to 23 after one month on Tamoxifen. Continue to monitor adrenal gland spot. Remain on Tykerb/Herceptin/Tamoxifen.
Nov'10~ Radiate positive mediastinal node that was pressing on recurrent laryngeal nerve, causing paralyzed larynx and a funny voice.
Jan'11~ MRI shows possible activity or perhaps just scar tissue/necrotic increase on 3 previously treated brain spots and a pituitary spot. 5 days of IMRT on 4 spots.
Feb'11~ Enrolled in T-DM1 EAP in Denver, first treatment March 25, 2011.
Mar'11~ Finally started T-DM1 EAP in Denver at Rocky Mountain Cancer Center/Rose on Mar. 25... hallelujah.
"I would rather be anecdotally alive than statistically dead."
|
|
|
06-28-2011, 01:20 PM
|
#3
|
Senior Member
Join Date: Jun 2011
Posts: 107
|
Re: Genentech/ TDM-1 info for making your voice heard
Hi, Thanks for the thread, I had read it.
My concern is that Genentech may only provide this drug to the women who are ---- currently on this trial---- letting them recieve it from their local oncologist. I am hoping women will call so they understand the great need there is for them to supply it to any woman who fits the criteria, even if that woman was NOT enrolled in the trial.
Traveling to the "closest" expanded access facility is not an option for me, therefore I won't be on this trial. So, according to what Genentech is proposing I would not be able to get this locally unless Genentech changes how they are currently writing up their ammended protocol to say.
Also, I talked to the nurse who was at the "closest" facility to me and she said this ----trial is closing ---in about 1 month.
|
|
|
06-28-2011, 08:42 PM
|
#4
|
Senior Member
Join Date: Oct 2005
Posts: 3,519
|
Re: Genentech/ TDM-1 info for making your voice heard
In my understanding, there are no firm guarantees or decisions yet about how anything will change and when... but if you want in the T-DM1 EAP and you qualify, personally, I would get moving swiftly to get into it at one of the accruing locations. Things can change quickly, so it's better to be in process than left out in the cold.
It's not only a Genentech decision, but also in concurrence w/ the FDA I think. There is so much that goes into shifting and changing protocols of trials when you are working towards approval to get it to market... most especially how all of the data from the ongoing trials is combined together so as to help and not adversely affect the eventual outcome/decision.
__________________
Brenda
NOV 2012 - 9 yr anniversary
JULY 2012 - 7 yr anniversary stage IV (of 50...)
Nov'03~ dX stage 2B
Dec'03~ Rt side mastectomy, Her2+, ER/PR+, 10 nodes out, one node positive
Jan'04~ Taxotere/Adria/Cytoxan x 6, NED, no Rads, Tamox. 1 year, Arimadex 3 mo., NED 14 mo.
Sept'05~ micro mets lungs/chest nodes/underarm node, Switched to Aromasin, T/C/H x 7, NED 6 months - Herceptin only
Aug'06~ micro mets chest nodes, & bone spot @ C3 neck, Added Taxol to Herceptin
Feb'07~ Genetic testing, BRCA 1&2 neg
Apr'07~ MRI - two 9mm brain mets & 5 punctates, new left chest met, & small increase of bone spot C3 neck, Stopped Aromasin
May'07~ Started Tykerb/Xeloda, no WBR for now
June'07~ MRI - stable brain mets, no new mets, 9mm spots less enhanced, CA15.3 down 45.5 to 9.3 in 10 wks, Ty/Xel working magic!
Aug'07~ MRI - brain mets shrunk half, NO NEW BRAIN METS!!, TMs stable @ 9.2
Oct'07~ PET/CT & MRI show NED
Apr'08~ scans still show NED in the head, small bone spot on right iliac crest (rear pelvic bone)
Sept'08~ MRI shows activity in brain mets, completed 5 fractions/5 consecutive days of IMRT to zap the pesky buggers
Oct'08~ dropped Xeloda, switched to tri-weekly Herceptin in combo with Tykerb, extend to tri-monthly Zometa infusion
Dec'08~ Brain MRI- 4 spots reduced to punctate size, large spot shrunk by 3mm, CT of torso clear/pelvis spot stable
June'09~ new 3-4mm left cerrebellar spot zapped with IMRT targeted rads
Sept'09~ new 6mm & 1 cm spots in pituitary/optic chiasm area. Rx= 25 days of 3D conformal fractionated targeted IMRT to the tumors.
Oct'09~ 25 days of low dose 3D conformal fractionated targeted IMRT to the bone mets spot on rt. iliac crest that have been watching for 2 years. Added daily Aromasin back into treatment regimen.
Apr'10~ Brain MRI clear! But, see new small spot on adrenal gland. Change from Aromasin back to Tamoxifen.
June'10~ Tumor markers (CA15.3) dropped from 37 to 23 after one month on Tamoxifen. Continue to monitor adrenal gland spot. Remain on Tykerb/Herceptin/Tamoxifen.
Nov'10~ Radiate positive mediastinal node that was pressing on recurrent laryngeal nerve, causing paralyzed larynx and a funny voice.
Jan'11~ MRI shows possible activity or perhaps just scar tissue/necrotic increase on 3 previously treated brain spots and a pituitary spot. 5 days of IMRT on 4 spots.
Feb'11~ Enrolled in T-DM1 EAP in Denver, first treatment March 25, 2011.
Mar'11~ Finally started T-DM1 EAP in Denver at Rocky Mountain Cancer Center/Rose on Mar. 25... hallelujah.
"I would rather be anecdotally alive than statistically dead."
|
|
|
06-28-2011, 09:44 PM
|
#5
|
Senior Member
Join Date: Apr 2011
Location: Michigan
Posts: 1,173
|
Re: Genentech/ TDM-1 info for making your voice heard
Can someone tell me the 10 states that have the TDM-1 trial drug?
|
|
|
06-29-2011, 06:02 AM
|
#6
|
Senior Member
Join Date: Jul 2008
Posts: 186
|
Re: Genentech/ TDM-1 info for making your voice heard
Here's link to entry in clinicaltrials.gov registry re: specifics of T-DM1 expanded use trial.
http://www.clinicaltrials.gov/ct2/sh...xpanded&rank=1
|
|
|
07-01-2011, 04:04 PM
|
#7
|
Senior Member
Join Date: Oct 2005
Posts: 3,519
|
Re: Genentech/ TDM-1 info for making your voice heard
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120561
Contacts
Contact: Trial Information Support Line 888-662-6728
Locations
United States, California Investigational Site Highland, California, United States, 92346
United States, California Investigational Site Stockton, California, United States, 95204
United States, Colorado Investigational Site Denver, Colorado, United States, 80220
United States, Florida Investigational Site Davie, Florida, United States, 33328
United States, Illinois Investigational Site Chicago, Illinois, United States, 60612
United States, Indiana Investigational Site Lafayette, Indiana, United States, 47905
United States, Iowa Investigational Site Cedar Rapids, Iowa, United States, 52403
United States, Kentucky Investigational Site Louisville, Kentucky, United States, 40245
United States, Michigan Investigational Site Detroit, Michigan, United States, 48201
United States, Missouri Investigational Site St. Louis, Missouri, United States, 63141
United States, South Carolina Investigational Site Charleston, South Carolina, United States, 29414
United States, Tennessee Investigational Site Nashville, Tennessee, United States, 37203
United States, Texas Investigational Site San Antonio, Texas, United States, 78229
United States, Virginia Investigational Site Fairfax, Virginia, United States, 22031
__________________
Brenda
NOV 2012 - 9 yr anniversary
JULY 2012 - 7 yr anniversary stage IV (of 50...)
Nov'03~ dX stage 2B
Dec'03~ Rt side mastectomy, Her2+, ER/PR+, 10 nodes out, one node positive
Jan'04~ Taxotere/Adria/Cytoxan x 6, NED, no Rads, Tamox. 1 year, Arimadex 3 mo., NED 14 mo.
Sept'05~ micro mets lungs/chest nodes/underarm node, Switched to Aromasin, T/C/H x 7, NED 6 months - Herceptin only
Aug'06~ micro mets chest nodes, & bone spot @ C3 neck, Added Taxol to Herceptin
Feb'07~ Genetic testing, BRCA 1&2 neg
Apr'07~ MRI - two 9mm brain mets & 5 punctates, new left chest met, & small increase of bone spot C3 neck, Stopped Aromasin
May'07~ Started Tykerb/Xeloda, no WBR for now
June'07~ MRI - stable brain mets, no new mets, 9mm spots less enhanced, CA15.3 down 45.5 to 9.3 in 10 wks, Ty/Xel working magic!
Aug'07~ MRI - brain mets shrunk half, NO NEW BRAIN METS!!, TMs stable @ 9.2
Oct'07~ PET/CT & MRI show NED
Apr'08~ scans still show NED in the head, small bone spot on right iliac crest (rear pelvic bone)
Sept'08~ MRI shows activity in brain mets, completed 5 fractions/5 consecutive days of IMRT to zap the pesky buggers
Oct'08~ dropped Xeloda, switched to tri-weekly Herceptin in combo with Tykerb, extend to tri-monthly Zometa infusion
Dec'08~ Brain MRI- 4 spots reduced to punctate size, large spot shrunk by 3mm, CT of torso clear/pelvis spot stable
June'09~ new 3-4mm left cerrebellar spot zapped with IMRT targeted rads
Sept'09~ new 6mm & 1 cm spots in pituitary/optic chiasm area. Rx= 25 days of 3D conformal fractionated targeted IMRT to the tumors.
Oct'09~ 25 days of low dose 3D conformal fractionated targeted IMRT to the bone mets spot on rt. iliac crest that have been watching for 2 years. Added daily Aromasin back into treatment regimen.
Apr'10~ Brain MRI clear! But, see new small spot on adrenal gland. Change from Aromasin back to Tamoxifen.
June'10~ Tumor markers (CA15.3) dropped from 37 to 23 after one month on Tamoxifen. Continue to monitor adrenal gland spot. Remain on Tykerb/Herceptin/Tamoxifen.
Nov'10~ Radiate positive mediastinal node that was pressing on recurrent laryngeal nerve, causing paralyzed larynx and a funny voice.
Jan'11~ MRI shows possible activity or perhaps just scar tissue/necrotic increase on 3 previously treated brain spots and a pituitary spot. 5 days of IMRT on 4 spots.
Feb'11~ Enrolled in T-DM1 EAP in Denver, first treatment March 25, 2011.
Mar'11~ Finally started T-DM1 EAP in Denver at Rocky Mountain Cancer Center/Rose on Mar. 25... hallelujah.
"I would rather be anecdotally alive than statistically dead."
Last edited by hutchibk; 07-01-2011 at 04:08 PM..
|
|
|
07-01-2011, 04:59 PM
|
#8
|
Senior Member
Join Date: Feb 2008
Location: South East Wisconsin
Posts: 3,431
|
Re: Genentech/ TDM-1 info for making your voice heard
|
|
|
Posting Rules
|
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts
HTML code is Off
|
|
|
All times are GMT -7. The time now is 09:47 PM.
|