Urgent - Petition to the FDA ODAC on the status of Omacetaxine for T315I

[Guest guest]

Hello Everyone,

As Cheryl-Anne Simoneau posted on Jerry's list, she was present and spoke to the

ODAC 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 their 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. 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. Hagop 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

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

Www.nationalcmlsociety.org www.cmlsociety.org