Urgent - Petition to the FDA Oncology Drug Advisory Committee/Omacetaxine

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Urgent- Petition to the FDA Oncology Drug Advisory Committee/Omacetaxine

http://www.petitiononline.com/FDAOMACE/petition.html

Hello Everyone,

....As Cheryl-Anne Simoneau with the CML Society of Canada had mentioned in a

post on Jerry Mayfield's New CML Drug site, she was present and spoke at the

ODAC meeting regarding the drug review for Omacetaxine. She did not speak as a

patient on the drug, but on behalf of all CML patients in general to plead the

case for the small minority of patients who unfortunately develop the T315I

mutation.

There were two patients with her who spoke to the advisory committee

members to relate their experience as patients diagnosed with the T315I

mutation, as well as relate their experience with Omacetaxine. For many patients

Omacetaxine is another lifeline in the journey and battle with CML and could

potentially help to remove the " sword of Damocles " hanging over their heads, and

indeed our own.

Usually the FDA ODAC committee votes on the clinical efficacy of the drug, but

in this case they chose to vote on the lack of a standardized test to determine

the presence of the T315I mutation. This is rather odd as no test currently used

to diagnose, or track our treatments are standardized at this time. That means

every test such as:

Bone marrow karyotype

Fluorescent In Situ Hybridization – FISH

Polymerase Chain Reaction testing – PCR

While we commend the work of the FDA and reviewing Omacetaxine, and indeed all

of our drugs currently used to treat this disease, we are dismayed by the sudden

change of policy.W

We are asking the FDA to re-visit their recommendation and allow Omacetaxine to

come to market while the company(ChemGenex) works with labs to standardize

mutation testing.

This is critical to patients who harbor the T315I. We do not know what

causes this mutation and we cannot really predict who will develop it, so this

could be the fate of any one of us.

Our doctors need more weapons in their arsenal for the treatment of CML – we are

not a one size fits all disease.

We wish to thank Dr. Mauro, Dr. Kantarjian and others for their

fantastic work in helping us put together this petition.

We need to accrue signatures as quickly as possible.

Please read the petition and if you are inclined, please sign it, and pass it

along to all your family and friends. Please also take the time to discuss this

with your doctor.

Patients who harbor the T315I mutation are orphans of an orphan disease – please

let's show our solidarity.

This is about standing by clinical efficacy and choices, this is not about brand

or drug loyalty.

The National CML Society (US) & the CML Society of Canada have joined our

resources together to put this petition forward.

Please review the petition and show your solidarity with your fellow CML

journeyers.

Please visit our websites and visit the petition page to read more about this

important situation.

Greg s & Cheryl Anne Simoneau

http://www.petitiononline.com/FDAOMACE/petition.html

www.nationalcmlsociety.org www.cmlsociety.org