Regorafenib do you know when is going to be approved by FDA?

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pepebcn
pepebcn Member Posts: 6,331 Member
edited January 2012 in Colorectal Cancer #1
No news about EMEA approval here yet!
Hugs!

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  • Lovekitties
    Lovekitties Member Posts: 3,364 Member
    #2
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    Dear Pepe
    I had never heard of this drug, but so very glad you asked about it.

    Here are two of many links I found from Oct. 2011:

    http://www.prnewswire.com/news-releases/phase-3-trial-of-investigational-compound-regorafenib-in-metastatic-colorectal-cancer-meets-primary-endpoint-of-improving-overall-survival-132598538.html

    http://www.medicalnewstoday.com/articles/236730.php

    Apparently is hasn't been approved, yet, by the FDA but it has been put on Orphan status to encourage additional testing and also has been put on fast track reviews.

    It sounds very promising and I certainly hope for all of us that approvals are very very soon!

    Hugs,

    Marie who loves kitties
  • pepebcn
    pepebcn Member Posts: 6,331 Member
    #3
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    Lovekitties said:

    Dear Pepe
    I had never heard of this drug, but so very glad you asked about it.

    Here are two of many links I found from Oct. 2011:

    http://www.prnewswire.com/news-releases/phase-3-trial-of-investigational-compound-regorafenib-in-metastatic-colorectal-cancer-meets-primary-endpoint-of-improving-overall-survival-132598538.html

    http://www.medicalnewstoday.com/articles/236730.php

    Apparently is hasn't been approved, yet, by the FDA but it has been put on Orphan status to encourage additional testing and also has been put on fast track reviews.

    It sounds very promising and I certainly hope for all of us that approvals are very very soon!

    Hugs,

    Marie who loves kitties

    Thks Marie!
    Hugs!
  • yoga
    yoga Member Posts: 87
    #4
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    thanks
    Thanks Pepe for making note of this and thanks Marie for the links. Something else I will be asking my onc about when I see him next week. Let's keep our fingers crossed that approval comes along soon!
    yoga jo
  • janie1
    janie1 Member Posts: 753 Member
    #5
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    yoga said:

    thanks
    Thanks Pepe for making note of this and thanks Marie for the links. Something else I will be asking my onc about when I see him next week. Let's keep our fingers crossed that approval comes along soon!
    yoga jo

    Was wondering, too, about
    Was wondering, too, about how it works. Hope it is something different from Erbitux and avastin. I saw on another site, it could be the end of this year when it could possibly be available. They thought that would be the earliest.
  • geotina
    geotina Member Posts: 2,111 Member
    #6
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    Pepe:
    From what I have read of this drug, it did very, very well in trials thus they terminated the trials to get it "fast tracked" thru the FDA for approval. Last infomation I read on it was on the Colon Cancer Alliance site.

    Take care - Tina
  • coloCan
    coloCan Member Posts: 1,944 Member
    #7
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    geotina said:

    Pepe:
    From what I have read of this drug, it did very, very well in trials thus they terminated the trials to get it "fast tracked" thru the FDA for approval. Last infomation I read on it was on the Colon Cancer Alliance site.

    Take care - Tina

    Pepe et al: phase III data on Regorafenib (Bay73-4506)
    and mCRC is to be presented Jan 21 in San Fran at the Gastrointestinal Cancers Symposium of ASCO.....Read this two minutes ago, 11:24 AM, NY time......
  • coloCan
    coloCan Member Posts: 1,944 Member
    #8
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    coloCan said:

    Pepe et al: phase III data on Regorafenib (Bay73-4506)
    and mCRC is to be presented Jan 21 in San Fran at the Gastrointestinal Cancers Symposium of ASCO.....Read this two minutes ago, 11:24 AM, NY time......

    For some further info on trials in US (K-Ras/Braf mutation)
    http://clinicaltrials.gov/ct2/show/NCT01298570
  • pepebcn
    pepebcn Member Posts: 6,331 Member
    #9
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    coloCan said:

    For some further info on trials in US (K-Ras/Braf mutation)
    http://clinicaltrials.gov/ct2/show/NCT01298570

    Thks Steve!
    Hugs!
  • coloCan
    coloCan Member Posts: 1,944 Member
    #10
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    pepebcn said:

    Thks Steve!
    Hugs!

    News of trial being reported in various press releases:
    thestreet.com/story/11378552/1/onyx-colon-cancer-drug-juggles-survival-benefit-with-severe-serious-side-effects.html

    or

    medicalxpress.com/news/2012-01-drug-survival-colorectal-cancer-patients.html

    or

    medicalnewstoday.com/article/240428.php

    among other sites

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