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Old 02-16-2012, 06:27 PM   #1
KDR
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FDA Grants Priority Review of Pertuzumab
http://www.modernmedicine.com/modern...tegoryId=40153

Action Date: 8 June 2012
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Old 02-16-2012, 08:51 PM   #2
Rich66
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Re: FDA Grants Priority Review of Pertuzumab
Quote:
The pertuzumab application is based on results from the pivotal phase 3 CLEOPATRA study. The study demonstrated a 6.1-month improvement in median progression-free survival (PFS) for people who received a pertuzumab-based regimen (pertuzumab combined with Herceptin and docetaxel chemotherapy) compared to those who received Herceptin and chemotherapy alone (median PFS 18.5 vs 12.4 months). People who received the combination also experienced a 38% reduction in the risk of their disease worsening or death (HR=0.62; P<.0001, according to independent review).
Hopefully they can expedite it beyond solely in combination with docetaxel, one of the harshest chemos.
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Old 02-16-2012, 08:58 PM   #3
ElaineM
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Wink Re: FDA Grants Priority Review of Pertuzumab
Good news !! Many people are waiting for this drug.
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Old 02-17-2012, 05:59 AM   #4
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Re: FDA Grants Priority Review of Pertuzumab
I need this drug.

Amelia
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Old 02-17-2012, 04:36 PM   #5
Adriana Mangus
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Re: FDA Grants Priority Review of Pertuzumab
I need it too!!!
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1994 - rt brst, .lump, underarm node dissection,chemo+rad 1.2 cms, Grade 3.
28 nodes neg
Er,Pr, Positive HER2 status unknown
2003- Recur to rt lung.July 16 ( B-Day!)
Her2+++ Er,Pr, Negative
2003 - Aug04--Navelbine + Herceptin
2004- 2007--NED - Herceptin, only
2007 Feb-April Xeloda added to hereceptin
2007-May Back on Navelbine+Herceptin
2008-Feb-Mar 15 Ses Rad to Rt. Lung
2008- Oc 17 Add Tykerb to Herceptin
2009- June-- Discont Tykerb
2009 July 7--Current Taxol + Herceptin
2009 Dec--Discontinued treatment due to progression. Looking into cyberknife.
2010-Aug Accepted to TDM1, no SE, except liver count went up.
2010-2011 September got kicked out of the trial, due to a small spot found on lung.
2011- 2012 September thru early 2013 on Herceptin
2013- March Bone density shows small spot on 5th rib.
2013 - April 4th appt with onc. will post after discussing course of treatment.
2013-March-April Cyber knife to brain and radiation to rib. Chest --base line before chemo-CT-Scan stable for lung issue. CA2729 Normal.
2013 April Herceptin- TDMI
2013 Sept Herceptin + Perjeta . CA2729 within normal range. Brain and Pet scans October 31st. will post results.
2013 October Brain MRI- mixed response. Will see Onc/rad on Halloween.
2013 October/November Brain-MRI nothing new. Repeat MRI next year in May.
2013 December Continue Herceptin and Perjeta. Stable at the moment.
2014 February Brain MRI -clear!
 2014 January Added Taxotere to Perjeta+Herceptin.
2014 March Stopped chemo-chest ct-scan next.
2014- March Scans shows tumor's larger, CA2729 higher. Discontinue Herceptin.
2014 April Perjeta+ Halaven
2014 April CA2729 went down 60 points after one cycle. Cough does not want to go away.
2014 June Continue on Perjeta + Halaven-- no more cough. Stable
2014 June Back on Herceptin + abraxane
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Old 02-17-2012, 05:14 PM   #6
yanyan
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Re: FDA Grants Priority Review of Pertuzumab
Does it mean the approval can be around July? How long does it take for them to make a decision and how long does it take to access patients once is approved. Thanks
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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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Old 02-18-2012, 05:13 AM   #7
Ellie F
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Re: FDA Grants Priority Review of Pertuzumab
Great news. Hopefully once approved in the States it will also get approved in the EU and sisters in England may also be able to benefit. i am hoping the bean counters do not stop this happening as was the case with tykerb!
Just to pick up Rich's point I would also be pleased to see it tested against other less toxic combos.
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Old 02-18-2012, 10:07 PM   #8
karen z
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Re: FDA Grants Priority Review of Pertuzumab
Thanks so much for posting.
Good news.
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