BMS Clinical Trial Access
Sign Now
We are forming this petition to request an immediate amendment to the entry criteria for the Phase II clinical trials of Dasatinib, an investigational drug by Bristol-Myers Squibb for the treatment of Chronic Myelogenous Leukemia. This request is on behalf of patients who have failed Imatinib Mesylate (Novartis, AG) therapy.
It is our understanding that there is a gap between the FDAs definition of IM failure and the current guidelines developed by world renowned CML experts*. Our evidence of this is based on the stringent entry criteria imposed on Bristol-Myers Squibb by the FDA for these trials which results in the exclusion of patients, often with fatal consequences.
Allowing treating physicians to use the guidelines developed by CML experts as the entry criteria will permit more patients access to the trials improving data accumulation, while prolonging lives.
Please amend the entry criteria so that patients who have failed IM therapy will have every opportunity to access this promising new drug now.
*(M. Talpaz, B.J. Druker, S.G. OBrien, J. E. Cortes, C. L. Sawyers, A.
Hochhaus, et al)
It is our understanding that there is a gap between the FDAs definition of IM failure and the current guidelines developed by world renowned CML experts*. Our evidence of this is based on the stringent entry criteria imposed on Bristol-Myers Squibb by the FDA for these trials which results in the exclusion of patients, often with fatal consequences.
Allowing treating physicians to use the guidelines developed by CML experts as the entry criteria will permit more patients access to the trials improving data accumulation, while prolonging lives.
Please amend the entry criteria so that patients who have failed IM therapy will have every opportunity to access this promising new drug now.
*(M. Talpaz, B.J. Druker, S.G. OBrien, J. E. Cortes, C. L. Sawyers, A.
Hochhaus, et al)
Sign The Petition
Continue with Google
OR
If you already have an account please sign in, otherwise register an account for free then sign the petition filling the fields below.
Email and password will be your account data, you will be able to sign other petitions after logging in.
Shoutbox
Goal
1,000 signatures
Goal: 10,000
Latest Signatures
17 January 2016
11 January 2016
8 January 2016
998.
Elizabeth Jf
|
I'm a the maximum dose of Gleevec; When that fails, this is all I have to stay alive
8 January 2016
8 January 2016
5 January 2016
25 December 2015
22 December 2015
17 December 2015
16 December 2015
10 December 2015
8 December 2015
8 December 2015
7 December 2015
4 December 2015
29 November 2015
23 November 2015
21 November 2015
19 November 2015
19 November 2015
18 November 2015
16 November 2015
979.
Jennifer R
|
If this drug has this good of results, then why let the govt. take it away? Cancer is the #1 killer in america and if something works, why change it?
11 November 2015
9 November 2015
24 October 2015
Tags
No tags
Embed Codes
direct link
link for html
link for forum without title
link for forum with title
