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

pepebcn

No news about EMEA approval here yet!
Hugs!

Lovekitties

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

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

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

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

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

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 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

coloCan said:

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

Thks Steve!
Hugs!

coloCan

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