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Old 02-07-2012, 07:50 PM   #1
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Roche’s new breast cancer drug Pertuzumab up for FDA review

U.S. health regulators, the Food and Drugs Administration (FDA) has granted a priority review for an experimental Roche breast cancer drug that in clinical trials added six months to the time before the disease worsened. Pertuzumab approval decision is due by June 8th this year. It could be used with Herceptin in HER2-positive patients. This was announced by Roche Holding AG's Genentech unit on Tuesday.

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Old 02-07-2012, 08:45 PM   #2
chrisy
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Re: Roche’s new breast cancer drug Pertuzumab up for FDA review

Good news, finally!

Wish they would reconsider TDM1...
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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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Old 02-07-2012, 10:01 PM   #3
karen z
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Re: Roche’s new breast cancer drug Pertuzumab up for FDA review

it is good news.
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