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Re: What is sutent?

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Hi,

It turns out that the Sutent drug inhibits c-kit and not bcr-abl. Gleevec

inhibits both of them. The Sutent drug helps about 60% of the GIST patients

who fail on Gleevec.

An excellent site for GIST. Worth joining.

http://www.gistsupport.org/

A complete description

http://www.gistsupport.org/SU11248.html

Sutent (formerly SU-11248, sunitinib malate)

Sutent is a tyrosine kinase inhibitor that has anti-cancer and

anti-angiogenesis effects. It was previously known as SU-11248, and its

chemical name is sunitinib malate. The cellular targets of this drug include

FLT3, KIT, PDGRFA, and VEGF-2. It has been tested against gastrointestinal

stromal tumor (GIST) and several other types of cancer in clinical trials.

On August 10, 2005 Pfizer released the following announcement about

submitting Sutent to the FDA for consideration of approval on fast-track

status:

Pfizer Submits Application for Sutent to FDA

NEW YORK, August 10 -- Pfizer Inc said today that it has submitted a New

Drug Application for its cancer medicine SU11248 (sunitinib malate), known

as Sutent, to the U.S. Food and Drug Administration.

Pfizer is seeking FDA approval for Sutent as a treatment for malignant

gastrointestinal stromal tumor and metastatic renal cell carcinoma among

patients whose tumors do not respond to or do not tolerate standard

treatment options.

The FDA has granted Sutent fast-track status since Sutent may provide

significant benefit over existing therapy for serious or life-threatening

illnesses for which no therapy exists.

Sutent is an oral, multi-targeted cancer therapy that combines

anti-angiogenic and anti-tumor activity to simultaneously stop the blood

supply to and directly attack tumor cells. Over 2,000 patients have received

Sutent as part of Pfizer's clinical trial program.

Developed by Pfizer, Sutent also is being studied alone and in combination

with other medicines as a treatment for a number of other solid tumors,

including breast, lung, prostate, and colorectal cancers.

Sutent is one of the first in a new class of drugs that selectively targets

multiple protein receptors, called receptor tyrosine kinases (RTKs).

Inhibition of these RTKs is believed to starve tumors of blood and nutrients

needed for growth and simultaneously kill the cancer cells that make up

tumors.

Pfizer is committed to advancing the scientific understanding of cancer and

to bringing new medicines that address unmet medical needs to cancer

patients. Oncology is a research priority for Pfizer, with a significant

portion of the company's research and development investment devoted to

discovering and developing innovative therapies for treating breast,

colorectal and other cancers.

In May 2005 the results of a Phase III trial assessing the efficacy and

safety of Sutent against gastrointestinal stromal tumor (GIST) were reported

at the ASCO meeting (abstract 4000). SUTENT showed benefit to about 60% of

imatinib-resistant patients in the trial. The following link takes you to

the abstract of this presentation and allows you to click “audio & slides”

to hear the presentation and see the slides shown.

Phase 3, multicenter, randomized, double-blind, placebo-controlled trial of

SU11248 in patients (pts) following failure of imatinib for metastatic GIST

G. D. Demetri, A. T. van Oosterom, M. Blackstein, C. Garrett, M. Shah, M.

Heinrich, G. McArthur, I. Judson, C. M. Baum, P. G. Casali

Here are links to other ASCO 2005 presentations about use of Sutent for

GIST.

Results from a continuation trial of SU11248 in patients (pts) with imatinib

(IM)-resistant gastrointestinal stromal tumor (GIST)

R. G. Maki, J. A. Fletcher, M. C. Heinrich, J. A. , S. , J.

Desai, K. Scheu, C. D. Fletcher, C. Baum, G. D. Demetri

Imaging kinase target inhibition with SU11248 by FDG-PET in patients (pts)

with imatinib-resistant gastrointestinal stromal tumors (I-R GIST)

A. van den Abbeele, Y. Melenevsky, D. de Vries, J. Manola, P. Dileo, R.

Tetrault, C. Baum, R. Badawi, G. Demetri

Availability of Sutent

Following the halt of the Phase III trial, manufacturer Pfizer is making

Sutent available through some of the former trial locations during the

interim period until the FDA reviews its application for approval. You can

find out more from Emerging Med. In addition, there are several new trials

for GIST with experimental combinations of Sutent together with Gleevec and

with other drugs. Please contact Emerging Med for more information at

http://www.gistsupport.org/clinical1.html or 866-729-1340. You may also want

to check the National Cancer Institute trials section at NIH Clinical

Trials.gov

Papers About Sutent

If you would like to read abstracts of other medical papers concerning

Sutent, this link displays PubMed listings for recent papers.

[ ] What is sutent?

Aug. 10, 2005: Pfizer applies for FDA approval of cancer drug Aug 11,

2005

Pfizer is seeking FDA approval for Sutent to treat a rare stomach

cancer called GIST (for gastrointestinal stromal tumors) and

metastatic renal cell carcinoma among patients whose tumors do not

respond to, or do not tolerate, standard treatment options. In a study

with Sutent, the drug proved effective in stanching growth of GIST in

385 patients who had developed resistance to the blockbuster cancer

drug Gleevec from Novartis. (Houston Chronicle -- Health)

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Are you saying that Gleevec caused GIST? Was the study completed w/CML patients

in mind or was it a coincidence?

kisocean <kisocean@...> wrote:Aug. 10, 2005: Pfizer applies for FDA

approval of cancer drug Aug 11,

2005

Pfizer is seeking FDA approval for Sutent to treat a rare stomach

cancer called GIST (for gastrointestinal stromal tumors) and

metastatic renal cell carcinoma among patients whose tumors do not

respond to, or do not tolerate, standard treatment options. In a study

with Sutent, the drug proved effective in stanching growth of GIST in

385 patients who had developed resistance to the blockbuster cancer

drug Gleevec from Novartis. (Houston Chronicle -- Health)

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No, this study is not saying that Gleevec caused GIST. GIST patients

also take Gleevec to treat their disease (Gleevec inhibits c-kit as well

as bcr-abl and GIST patients tumors are fueled by c-kit as ours are

fueled by bcr-abl). GIST patients can also become resistant to Gleevec

just as CML patients can and Sutent is a drug that can be used by GIST

patients who become resistant to Gleevec.

Dorothy

Yrulooknback wrote:

> Are you saying that Gleevec caused GIST? Was the study completed w/CML

> patients in mind or was it a coincidence?

>

> kisocean <kisocean@...> wrote:Aug. 10, 2005: Pfizer applies

> for FDA approval of cancer drug Aug 11,

> 2005

> Pfizer is seeking FDA approval for Sutent to treat a rare stomach

> cancer called GIST (for gastrointestinal stromal tumors) and

> metastatic renal cell carcinoma among patients whose tumors do not

> respond to, or do not tolerate, standard treatment options. In a study

> with Sutent, the drug proved effective in stanching growth of GIST in

> 385 patients who had developed resistance to the blockbuster cancer

> drug Gleevec from Novartis. (Houston Chronicle -- Health)

>

>

>

>

>

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Wow! I didn't know that about c-kit thanks Dorothy...

Dorothy Emery <doemery@...> wrote:No, this study is not saying that

Gleevec caused GIST. GIST patients

also take Gleevec to treat their disease (Gleevec inhibits c-kit as well

as bcr-abl and GIST patients tumors are fueled by c-kit as ours are

fueled by bcr-abl). GIST patients can also become resistant to Gleevec

just as CML patients can and Sutent is a drug that can be used by GIST

patients who become resistant to Gleevec.

Dorothy

Yrulooknback wrote:

> Are you saying that Gleevec caused GIST? Was the study completed w/CML

> patients in mind or was it a coincidence?

>

> kisocean <kisocean@...> wrote:Aug. 10, 2005: Pfizer applies

> for FDA approval of cancer drug Aug 11,

> 2005

> Pfizer is seeking FDA approval for Sutent to treat a rare stomach

> cancer called GIST (for gastrointestinal stromal tumors) and

> metastatic renal cell carcinoma among patients whose tumors do not

> respond to, or do not tolerate, standard treatment options. In a study

> with Sutent, the drug proved effective in stanching growth of GIST in

> 385 patients who had developed resistance to the blockbuster cancer

> drug Gleevec from Novartis. (Houston Chronicle -- Health)

>

>

>

>

>

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