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02-22-2013, 08:05 AM
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#1
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Senior Member
Join Date: Nov 2010
Posts: 393
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T DM-1 Approved !!
Finally, This FDA approved " Kadcyla" ( TDM-1 ) for her2 + pts who have progressed on " herceptin and a taxane " , now many , many more lives will be saved, and pts like Lorraine can get the drug the way they and their doc want it, the healthiest way.
we will still fight for full approval for early stage iv pts, sparing them from taxanes ...
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02-22-2013, 08:08 AM
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#2
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Senior Member
Join Date: Aug 2010
Location: New York, New York
Posts: 1,580
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Re: T DM-1 Approved !!
YES YES YES JUST GOT THE EMAIL BRING IT ON
Karen
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02-22-2013, 11:11 AM
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#3
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Senior Member
Join Date: Mar 2012
Posts: 61
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Re: T DM-1 Approved !!
Fantastic!
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02-22-2013, 11:22 AM
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#4
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Senior Member
Join Date: Dec 2011
Posts: 585
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Re: T DM-1 Approved !!
This is wonderful news! Thank you so much, Phil, for everything you did to make this happen, and all the attention you brought to this situation. Also, thank you to all the ladies who participated in the trials. None of this would have happened if it wasn't for courageous people like you, who inspire the rest of us. <3 Might I just say, YAY!!!!
__________________
Diagnosed in October 2011 Stage IV with metastasis to liver.
January 2012 after double mastectomy, started taxotere, carboplatin and herceptin.
Clear.
December 2012 was diagnosed with five brain mets, and had whole brain radiation.
Around July 2014 two mets in brain, one a residual spot and one new one growing in size. Received Cyberknife on both areas
Clear/NED
April 2015 remain NED
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02-22-2013, 11:31 AM
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#5
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Senior Member
Join Date: Sep 2005
Location: Central Coast, CA
Posts: 3,207
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Re: T DM-1 Approved!!
YES, finally! Too bad there is not enough data yet on adjuvant, or enough juice to allow it to be a first-line treatment for Stage 4 (although there is a tiny loophole if someone progressed within 6 months after H and a Taxane).
On the back end tho, it's good to see it's not restricted (like Perjeta) to first or second line....so all those who have been fighting through multiple lines of treatment will have access.
Still wish it had been 2 years ago!
__________________
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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02-22-2013, 11:31 AM
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#6
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Senior Member
Join Date: Feb 2007
Location: Paris, France
Posts: 858
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Re: T DM-1 Approved !!
What good news! It took so so long....
Phil, thank you for fighting for all of us.
And now Europe??? Anybody know?
Michka
__________________
08.2006 3 cm IDC Stage 2-3, HER2 3+ ER+90% PR 20%
FEC, Taxol+ Herceptin, Mastectomy, Radiation, Herceptin 1 year followed by Tykerb 1 year,Aromasin /Faslodex
12.2010 Mets to liver,Herceptin+Tykerb
03.2011 Liver resection ER+70% PR-
04.2011 Herceptin+Navelbine+750mg Tykerb
06.2011 Liver ned, Met to sternum. Added Zometa 09.2011 Cyberknife for sternum
11.2011 Pet clear. Stop Navelbine, continuing on Hercpetin+Tykerb+Aromasin
02.2012 Mets to lungs, nodes, liver
04.2012 TDM1, Ned in 07.2012
04.2015 Stop TDM1/Kadcyla, still Ned, liver problems
04.2016 Liver mets. Back on Kadcyla
08.2016 Kadcyla stopped working. mets to liver lungs bones
09.2016 Biopsy to liver. no more HER2, still ER+
09.2016 CMF Afinitor/Aromasin/ Xgeva.Met to eye muscle Cyberknife
01.2017 Gemzar/Carboplatin/ Ibrance/Faslodex then Taxotere
02.2017 30 micro mets to brain breathing getting worse and worse
04.2017 Liquid biopsy/CTC indicates HER2 again. Start Herceptin with Halaven
06.2017 all tumors shrunk 60% . more micro mets to brain (1mm mets) no symptoms
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02-22-2013, 01:12 PM
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#7
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Senior Member
Join Date: Sep 2001
Location: California's Gold Country
Posts: 404
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Re: T DM-1 Approved !!
Whooo Hooo.....Such great news!
Yes, thank you Phil and all the brave trial volunteers.
Kim
__________________
Diag. Feb 1997 4.5cm IDC <10%ER+, PR-. 5 out of 36 nodes +. Mastectomy followed by 3 rounds Adriamycin/Cytoxin.
5/1997 Hi Dose Chemo w/ Stem cell rescue. Spent 4 weeks in isolation ward. Then 6 weeks radiation.
9/2001 widespread mets to liver. 8 mos Taxotere/Herceptin brought me almost to NED. Stop Taxotere & add Femara .
11/2002 liver resection to remove spot that turned out to be necrosis. Officially NED!
7/2003 Tumor markers rising add Xeloda Disastrous reaction, 8 days hospital, but tumor markers came back to normal!
June -Dec 2004 UW Vaccine Trial.
7/2005 MRI single 11mm brain met
8/2005 Gamma Knife.
Brain MRI @3 months NED!
2006-2011 brain/body still NED
8/04/11 Taking Herceptin break, will monitor with tumor markers.
6/20/12 Tumor markers begin to rise. CA15-3 is 31.3 and Her2 Serum is at 17.1 Decide to repeat in one month.
7/23/12 CA15-3 now 49.3
Her2 Serum 26.8
8/6/12 Back on Herceptin
CA15-3 now 76
Her2 Serum now 49
11/7/12 Add weekly Taxotere for 4 cycles
2/2013 Stopped Taxotere added Perjeta. MRI shows approx. 50% reduction liver mets. CA15-3 still elevated @ 55. Will continue on just Herceptin & Perjeta.
November 2014 Continuing on Herceptin, Perjeta, and
Femara indefinitely. Guess I'm NED again, but watching those tumor markers carefully!
Dec. 2015 PET scan reveals mass in perirectal area of abdomen.biopsy confirms. Still Her2+, but no longer ER+. Bye bye Femara
Jan 2016 Begin Kadcyla
March 2016 PET scan shows tumor now barely visible, still NED everywhere else.
2016/2017 continue Kadcyla
November 2017 brain MRI reveals small focus of T2 hyperintensity with possible 4mm enhancing nodule. Short term follow up MRI suggested. Stay tuned...
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02-22-2013, 01:39 PM
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#8
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Senior Member
Join Date: Aug 2010
Location: New York, New York
Posts: 1,580
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Re: T DM-1 Approved !!
http://www.nytimes.com/2013/02/23/bu...g.html?hp&_r=0
New York Times article-
Phil, take note on the last line, something tells me the writer might have been referring to you? (Means you, Lorraine, and all the others have been recognized).
Today, when I got the text from a company rep about the approval, I jumped out of my seat in the waiting room of my treatment center. I felt such a sense of elation, but also of validation. Since I've been on this trial, two of the drugs have been approved, Perjeta and Kadcyla. It has not been an easy road, being so carefully monitored. But look at the reward. I am proud to have paved even one brick in the road for others.
Like my yoga instructor, Regina, says: "Service to others is the price we pay for being here."
Karen
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02-22-2013, 02:04 PM
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#9
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Member
Join Date: Nov 2012
Posts: 23
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Re: T DM-1 Approved !!
So Happy!!! FDA comes through!!!!!!!!!!!!!!!!!!!!!
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02-22-2013, 03:04 PM
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#10
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Senior Member
Join Date: Dec 2009
Posts: 562
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Re: T DM-1 Approved !!
My doctor said he'd put me on it as soon as it was approved, so we'll see. I am not sure how long it'll take to filter down to clinics and if nurses need to be trained. But I am very happy and hopeful that it will give me some more time. 
__________________
 http://butdoctorihatepink.com
08/17/09 Dx'd.
Multifocal/multicentric IDC, largest 3.4 cm, associated ADH, LCIS, DCIS
HER2+ ER+/PR- Grade 3, Node Negative
10/20/2009: Right mastectomy, reconstruction with TE
12/02/2009: Six rounds TCH, switched to Taxol halfway through due to neuropathy
03/31/2010: Finished chemo
05/01/2010: Began tamoxifen, the worst drug ever
11/18/2010: Reconstruction completed
12/02/2010: Finished herceptin
05/21/2011: Liver Mets. Quit Tamoxifen
06/22/2011: Navelbine/Zometa/Herceptin
10/03/2011: Liver Resection, left lobe. Microwave ablation, right lobe - going for cure!
11/26/2011: C-Diff Superbug Infection, "worst case doctor had seen in 20 years"
03/28/2012: Progression in ablated section of the liver - no more cure. Started Abraxane, continue herceptin/zometa
10/10/2012: Progression continues, started Halaven, along with herceptin and zometa.
01/15/2013: Progression continues, started Gemzar and Perjeta, an unusual combo, continuing with herceptin and zometa
03/13/2013: Quit Gemzar, body just won't handle it. Staying on herceptin, zometa and perjeta.
04/03/2013: CT shows 50% regression in tumor, so am starting back on Gemzar with dose reduction, staying with perjeta/herceptin/zometa. Can't argue with success!
05/09/2013: Discussing SBRT with Radiology due to inability of bone marrow to recover from chemo.
06/07/2013: Fiducial placement for SBRT
07/03/2013: Chemo discontinued, on Perjeta, Herceptin and Zometa alone
07/25/2013: SBRT (gamma knife) begins
08/01/2013: SBRT completed
08/15/2013: STABLE! continuing with Perjeta, Herceptin, Zometa
06/18/2014: ***** NED!!!!***** continuing with Perjeta, Herceptin, Zometa
01/29/2014: Still NED. continuing with Perjeta, Herceptin. Zometa lowered to every 3 months instead of monthly.
11/08/2015: Progression throughout abdomen and lungs. Started TDM-1, aka Kadcyla. Other meds discontinued. Remission was nice while it lasted.
5/27/18: Stable. Kadcyla put me right back in the barn. I have two teeny spots on my lungs that are metabolically inactive, and liver is clean.
I’m beating this MFer. I was 51 when this started and had two kids, 22 and 12. Now I’m 60. My oldest got married and trying to start s family. My youngesg graduates from Caltech this June. My stepdaughter gave me grandkids. Life is fantastic.
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02-22-2013, 03:07 PM
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#11
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Senior Member
Join Date: Apr 2011
Posts: 403
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Re: T DM-1 Approved !!
Many many many grateful thanks to those who made this finally happen !!!!!
__________________
1/11 age 36 DX
ER/PR-, Her2 +
TCH*6, Herceptin
BMX with immediate recontruction 5/2011 Lattismus Flap- Dx stage 3c 10/23 nodes
9/11 Radiation
3/12 Local recurrence to skin stage IV
Whole body scan CLEAR
4/12 Tykerb & Xeolda Skin mets slowly regressing
8/12 PET & Brain CT Clear
5/13 Skin mets progressing
6/13 PET scan chestwall recurrence in contralateral anxillary,internal mammary and ipsilateral subpectoral nodes
6/13 kadcyla
10/13 whole body scan -clear NED. previously resolved skin rash gone but 3 new lesions. Biopsy confirmed for skin recurrence
11/13 to 02/14 tykerb & herceptin
02/14 add abraxane/gemzar, 2 weeks on 1 week off at reduced dose
05/14 whole body PET clear/ brain CT clear but skin mets are getting worse, ready for new chemo
05/14 navelbine perjeta herceptin
07/14 skin mets progressing red rash worse
08/14 wide local excision with diep flap to close wound. Final path shows 2 positive margins showing inflammatory carcinoma Going back to surgery in 2 weeks
09/01/14 resection- clear margins
3 weeks after 2nd surgery, a new nodular rash found near drain incision with 2 small red spots behind the chest wall biopsy on 10/1. Positive for breast cancer
Radiation 11/2014 with xeloda then weekly cisplatin
11/14 brain MRI clean
12/14 finished 33 radiations burnt and very painful. Bedridden for 1 week
12/14 t current Herceptin and perjeta only
02/15 rash on upper back right side skin mets radiation planned
02/15 staring electron radiation *35
Stopped at 30 due to severe skin burn, resumed 10 days later
05/15 red patches appeared in between previously radiated area, skin mets. Ct and brain Mri clear. Simulation planned, radiation to start after trip to Alaska.
05/24 new spot identified in scar line on previously radiated reconstructed breast- electron on both side chest wall area and scar line
07/15 multiple skin and lung recurrence begin halaven
11/15 cough much better but very tired on halaven and starting to see some new red skin blotches-suspicious
11/15 heading to China for immune therapy
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02-22-2013, 06:43 PM
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#12
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Senior Member
Join Date: Jul 2011
Location: Sydney, Australia
Posts: 473
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Re: T DM-1 Approved !!
This is wonderful news, and thanks Phil and all concerned for your amazing efforts. My onc recently offered me TDM-1 under compassionate use as it's not approved here in Australia of course. I chose to try Abraxane again (which seems to be working again thankfully). However, I wrote to our Federal Health Minister and this was the reply (for the interests of other Aussies reading). From what she says I think we need to work with Roche or the lobby groups. Cheers Marie
Regarding your query, in order for a prescription medicine, including an orphan drug, to be included in the Australian Register of Therapeutic Goods, an Australian sponsor is required to submit an application accompanied by scientific and clinical data to demonstrate the quality, safety and efficacy of the product for its intended use.
The Therapeutic Goods Administration reviews the data and will usually seek the advice of an independent expert advisory committee before making a decision to approve or reject a new product. The Australian Government is not able to compel a sponsor to submit an application to register a medicine in Australia and approval for marketing cannot be given in the absence of an application. However, due to commercial-in-confidence issues, the Therapeutic Goods Administration isn’t able to advise if there has been an application for either of the drugs you refer to and or where it's up to.
Thank you again for taking the time to write to me and I wish you all the best with your treatment. It is an onerous process and I hope you are surrounded by a wonderful support network.
Best wishes,
Tanya
__________________
dx Dec 2000 dcis 2.5cm clear sentinel node, ER/PR- Her-2+
lumpectomy, 6 cycles AC, 6 weeks rads
October 2007 three x 2.5cm lung mets. 8 months Taxol, started Herceptin and continue. Significant reduction in lung mets.
June 2011 3cm x 4cm liver tumour. Started Abraxane and continue with Herceptin.
November 2011. Finished with Abraxane, continue with just Herceptin. Liver tumour now reduced to 15mm x 12mm. Lung tumour now 10mm x 0.5mm
February 2012. Scans show everything stable, and brain scan clear.
July 2012. PET/CT scans show I'm in remission - no active cancer!
]Dec CT brain cllear, lungs stable, liver tumour has increased to 20mm. PET scans showed active liver met and active lung thinglet, and possible bone met.
Jan 2013 recommence Abraxane, continue with Herceptin.
June 2013 finish Cycle 6 Abraxane, continue with Herceptin. 30% reduction in liver tumour, everything stable.
December 2013. CA15-3 on rise.
February 2014. PET and CT scans show single liver tumour has increased to 35mm. No other activity.
March 2014. Planned for SBRT for liver met, but couldn't have treatment as tumour too close to bowel. Continue Herceptin.
April 2014. Surgeon advises that I am a good candidate for liver resection, so will have operation early May (after camping holiday). Tumour now 44mm x 29mm.
May 7, 2014. Two liver tumours surgically removed. Third of liver removed, and gall bladder. Am I NED?May 2014. Pathology of tumour shows it's now ER+ (95% staining).
June 2014. CA15-3 has decreased to 18 from a pre-surgery reading of 59!
June 2014. Started Femara, continue with Herceptin.
July 2014. Stop Femara due to severe Osteoporosis. Commence Tamoxifen, continue Herceptin. Waiting to hear if I can have Aclasta infusion.
August 2014. CA15-3 has decreased further to 12 - YAY!
October 2014. Aclasta infusion for Osteoporosis. November 2014, CA15-3 decreased to 11. Scans of liver all clear, something new showing up on lung, but just watching at the moment.
November 2015. Started SBRT on solitary lung met.
November 2015. Bone density scan showed very good improvement so back on Femara - yay!
December 2016. 6 treatments of SBRT radiation on lung. Seems to have had some effect.
June 2016. CA15-3 still stable and low at 9.
June 2016. Started subcutaneous Herceptin replacing infusion.
Jan 2017. LVEF dropped to 46%. Stopped Herceptin.
Feb 2017. Started ACE Inhibitor and BETA Blocker. Still off Herceptin.
Aug 2017. Two new mets - Portacaval lymph node and mediastinal lymph node.
Aug 2017. Blood tests show extremely elevated liver enzyme levels. Many tests to investigate.
Sept 2017. Portacaval lymph node blocking liver bile duct causing liver enzyme and Bilirubin problems.
Oct 2017. 8cm stent inserted into liver bile duct. Procedure caused pancreatitis, and hospitalised for 3 days. Liver enzymes improving rapidly.
Nov 2017. Commenced 4 weeks of radiation on Portacaval lymph node. 5 week break before chemo.
Jan 2018. CT scan. 11 new small liver mets, and new superclavical lymph node med.
Jan 2018. Start Kadcyla. CA15-3 426.
Apr 2018. First scans since starting Kadcyla. All tumours reducing. CA15-3 dropped to 30 from 426.
Dec 2019. Still on Kadcyla, but two small brain mets have been treated in the past month with SRS. CA15-3 stable for 12 months at 11.
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02-22-2013, 08:25 PM
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#13
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Senior Member
Join Date: Nov 2010
Posts: 393
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Re: T DM-1 Approved !!
I have corresponded with Mr. Pollack at NYT. I dont see any reference to us in the online version. His article is the most balanced so far , but even there the warning about liver toxicity , death is not challenged. The FDA " Establishment " goes un-challenged. We have heard of only 2 deaths thru liver failure , early in trials, both with pre-existing conditions. there are platelet , red count issues , but many do not have them , and many, like Lorraine have found a way to manage them. overall side effects are much better than tyk /xel, taxanes . When Lorraine saw side effect stuff put out by This biased FDA , she said " I'll talk about side effects , how about fingers split open , bleeding all winter from tyk/xel, losing 15 lbs off an already skinny chemo body with awful gi upset " Thats the story that shoud be told. Dr. Snydermans NBC story tonight was very brief, pessimistic, ( "its not a cure , costly, bad s/e 's, blah , blah " ) she must have been briefed by This FDA. as the NYT says its costs are comparative to other tx's . we know s/e's are overall less than old chemos, and cure ? its too early to tell either way , but Lorraine and many others are yrs ned. if This FDA ever gets it to early dx stage iv , ned rates will go up. CNN article ? says its anew drug Its NOT a " new " drug, its been around since 2006 in human trials , and it was featured at San Antonio way back in 2009. We have to fight for our rights , against propaganda from This FDA Establishment . The Fight is far from over !
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02-22-2013, 08:34 PM
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#14
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Senior Member
Join Date: Apr 2008
Location: Sunny San Diego
Posts: 2,214
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Re: T DM-1 Approved !!
WooHoo Phil!!!
Awesome. I am so thrilled. First Perjeta and now TDM1. I see real progress in the treatments available. I may never need them, but I am comforted by the increased options.
Cool Breeze, you aren't done yet. I have a feeling I'll be following your blog for a long, long time. And voting, lol.
__________________
Diagnosed 2007
Stage IIb Invasive Ductal Carcinoma, Pagets, 3 of 15 positive nodes
Traditional Treatment: Mastectomy and Axillary Node Dissection followed by Taxotere, 6 treatments and 1 year of Herceptin, no radiation
Former Chemo Ninja "Takizi Zukuchiri"
Additional treatments:
GP2 vaccine, San Antonio Med Ctr
Prescriptive Exercise for Cancer Patients
ENERGY Study, UCSD La Jolla
Reconstruction: TRAM flap, partial loss, Revision
The content of my posts are meant for informational purposes only. The medical information is intended for general information only and should not be used in any way to diagnose, treat, cure, or prevent disease
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02-23-2013, 12:24 AM
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#15
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Senior Member
Join Date: Sep 2005
Location: Central Coast, CA
Posts: 3,207
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Re: T DM-1 Approved !!
Yes, I'll talk about side effects too! I was on it for 3+ years and it was like being on vacation. In fact, I did a lot of vacationing during that time...
Seriously, it should have been approved long ago, and hopefully soon there will be a path to access as a single agent without having to do taxanes.
Phil, I told you it would be announced on a Friday . But at least it was in the morning, so hopefully it will get some discussion.
Overall a good day, but you're right, the fight is not over.
__________________
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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02-23-2013, 03:31 AM
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#16
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Senior Member
Join Date: May 2010
Posts: 432
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Re: T DM-1 Approved !!
It is GREAT to get such wonderfull news.
Hope the Drug Controller here approves it
__________________
PBK
huband of Hema
Metstatic Breast Cancer Stage 4
Left breast cauliflower 25x20cm
ossousmetstatis in vertbrae secondaries L4=L5secondary
nodules in both liver lobes secondary
Diagnosed 10th March 2010
ER/PR-ve
Her 2 neu +++
Taxotrne Zylotec started 16th March
Herceptin added 5th April.9th Herceptin over on 20th Sep '10.Started on Tykerb and Xeloda on 22nd Oct2010TYKERB 4 TAB A DAY XELODA 4 TAB A DAY ONE WEEK ON ONE WEEK OFFZoletrust infusion every 4 months.Lesion in Brain 3D CRT Radiation started on 1st Feb'12 for 20 days ,5 days a week for 4 weeks.Devloped a small lump in breast.Xeloda stopped from 11th April '12.On Taxol.After 3 cycles of Taxol Taxol stopped.Back to Xeloda regime from 3rd July
Herceptin started again on 27th Dec 2012.Xeloda stopped Navelbin added on 7th February 2013.Now on Tykerb Herceptin and Navelbin
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02-23-2013, 05:59 AM
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#17
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Senior Member
Join Date: Feb 2009
Posts: 1,526
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Re: T DM-1 Approved !!
Wow Phil, do you want to come and fight for the ladies in Europe! Don't know how long before approved by the EU then of course it will have to get past the bean counters at NICE!
Concerned that we at end up in the same boat as we did with tykerb!
That aside well done for for all your efforts
Ellie
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02-23-2013, 06:15 AM
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#18
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Senior Member
Join Date: Aug 2011
Location: Philly Suburbs
Posts: 1,709
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Re: T DM-1 Approved !!
Yay!
What great news!!
Phil...well done!
All you ladies who braved the trials...THANK YOU, from all of us to follow!
My only sad thought was...I just wish it crossed the blood brain barrier...too bad for me.
But still jumping up and down for the rest of you!!! A great day for all of us!
Denise
__________________
1/11-needle biopsy
2/11-Lumpectomy/axillary node dissection - Stage 3c, ER/PR-14/17 nodes
3/11 - Post-op staph infection,cellulitis, lymphedema,seroma,ARRRGH!
4/12/11-A/C x 4, then T/H x 4, H only,Q3 weeks
8/26/11 finished Taxol!!!
10/7/11 mastectomy/DIEP recon
11/11 radiation x28
1/12/12 1st CANCER-VERSARY!
1/12 Low EF/Herceptin "Holiday" :(
2/12 EF up - Back on Herceptin, heart meds
4/2/1212 surgery to repair separated incision from DIEP recon
6/8/12 Return to work :)
6/17/12 Fall, shatter wrist,surgery to repair/insert plate :(
7/10/12 last Herceptin
7/23/12 Brain Mets %$&#! 3cm and 1cm
8/10/12 Gamma knife surgery, LOTS of steroids;start H/Tykerb
8/23/12 Back to work
12/20/12 Injure back-3 weeks in wheel chair
1/12/13 2nd CANCER-VERSARY!
1/14/13 herniate disk in back - surgery to repair
1/27/13 Radiation necrosis - edema in brain - back on steroids - but not back to work - off balance, poor cordination in right arm
5/3/13 Start Avastin to shrink necrosis
5/10/13 begin weaning steroids
6/18/13 Brain MRI - Avastin seems to be working!
6/20/13 quarterly CT - chest, abdomen, pelvis - All Clear!
7/5/13 finally off steroids!!
7/7/13 joined the ranks of the CHEMO NINJAS I am now Tekuto Ki Ariku cancer assassin!
7/13/13 Symptoms return - back on steroids
7/26/13 Back on Avastin - try again!
8/26/13 Not ready to return to classroom yet :( But I CAN walk without holding onto things! :)
9/9/13 Brain MRI - fingers crossed
“ Life is a grindstone, and whether it grinds you down or polishes you up is for you, and you alone, to decide. ” – Cavett Robert
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02-23-2013, 01:51 PM
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#19
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Senior Member
Join Date: Jul 2008
Posts: 186
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Re: T DM-1 Approved !!
Denise, with BC spreading to brain a not so infrequent occurrance, how much longer will it be before t-dm1 is studied in intrathecal trials? If proven successful, i.e. a breakthrough technology, groundwork is now in place that enables a much faster approval process.
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02-23-2013, 03:14 PM
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#20
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Senior Member
Join Date: Aug 2010
Location: New York, New York
Posts: 1,580
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Re: T DM-1 Approved !!
Hey, Denise,
The brain issue is definitely a concern, for me and others. But I have been told that if you are non-hypermetabolic from the neck down, chances are cancer will not rise above the neck in this state. Now that Kadcyla is approved, I'll be checking on whether to add Tykerb.
OK, so Kadcyla party was yesterday. Now, let's move on, starting today, to get the next best thing (or better) approved. Next...
Warmly
Karen
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