Revlimid FDA Review
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June 8, 2005 at 8:21 pm #6692KP2112Member
Hi Everyone,
Yesturday the FDA agree to review Celgene Corporation ‘s New Drug Application for Revlimid. This means that the next step is potentially accessibility to the medication, if approved.
I have composed a letter to the FDA encouraging them to approve the drug. I have provided it below. Please let me know if you would like me to attach your name or any neames of friends and families that might want to be a part of it. I think it is important to do this as I am sure many could benefit from its use. Next hurdle Exjade!
June X, 2005
Mr. Lester M. Crawford, D.V.M., Ph.D
United States Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857Dear Mr. Lester M. Crawford,
I am writing this letter to you on behalf of the many people affected by Myelodysplastic Syndromes (MDS). MDS is a potentially life threatening condition which prevents the bone marrow from producing healthy blood cells and instead produces poorly functioning and immature ones. It is estimated that in the United States alone, 20,000 to 30,000 new cases are diagnosed each year with that number expected to rise. In some cases MDS is associated with chromosomal abnormalities such as a 5q deletion and many cases can also progress into Acute Myeloid Leukemia (AML). Although there is no one treatment that is effective for those affected by MDS, novel drugs and combination therapies are continually being developed.
Revlimid (lenalidomide) is a treatment that has been developed by the Celgene Corporation. Revlimid has been identified through almost 30 clinical trials as being an effective therapy for MDS. A 115 person Revlimid study, headed by Dr. Alan List of the H.Lee Moffitt Cancer Centre in Tampa, Florida, produced results of a 66% reduction or elimination of blood transfusions in transfusion-dependent MDS patients. More significantly, the same study found that the most common genetic mutation (5q deletion) fueling the syndrome, diminished in 81 patients and vanished in 51. As Revlimid is a highly effective advancement in MDS therapy, there is an urgent need for Revlimid’s approval for use as a MDS treatment.
The purpose of this letter is to strongly encourage FDA approval of Revlimid. Approval would provide MDS patients with an improved treatment regime and lessen the need for transfusions and highly toxic alternative treatments. Revlimid also has the ability to help those MDS patients with a 5q deletion (where no other comparable treatment exists), thus extending and saving the lives of tens of thousands of people worldwide. On behalf of MDS patients everywhere, I implore your timely approval of Clegene Corporation’s New Drug Application for Revlimid, submitted April, 2005.
We have lost too many lives to the devastation of this disease family, friends and children included. Notable individuals such as U.S. Senator Paul Tsongas (D-MA); U.S. Rep. Joseph Moakley; Scientist Carl Sagan; Scientist Marie Curie; and Former First Lady Eleanor Roosevelt succumbed to MDS as well.
I trust your sincere regard for this matter and look forward to hearing from you.Sincerely,
June 9, 2005 at 2:54 am #6693DickMemberYes
Please my name to your letter.
Dick Frans
CaliforniaJune 9, 2005 at 4:38 am #6694Kathy GMemberYou did a great job – please add my name to the list.
Kathy Gratteau
TennesseeJune 9, 2005 at 12:24 pm #6695SuzanneMemberAdd mine too
Suzanne Duncan
MarylandJune 9, 2005 at 12:31 pm #6696John in GRMemberPlease add mine.
John Hess
Grand Rapids, MichiganJune 9, 2005 at 1:00 pm #6697shirlsgirlMemberKaren,
Very well written..awesome! Add me please.
Jody Donaldson
Hamilton,Ontario
CanadaJune 9, 2005 at 1:33 pm #6698MarshaMemberGreat letter! Add me too!
Marsha Warmke
WisconsinJune 9, 2005 at 2:01 pm #6699frankParticipantme…
Shoufang Chen.
need my twins??? just kidding..
Frank
June 9, 2005 at 2:16 pm #6700CarlMemberKaren,
Great letter! Please add me as a supporter and co signer.
Carl Siddall
AlabamaJune 9, 2005 at 2:23 pm #6701gemloyearMemberPlease add our names, thanks so much, great job
Glen Loyear
Eleanor Loyear
Duluth,Mn.June 9, 2005 at 2:58 pm #6702covergirlMemberPlease add me also and thanks for doing a great job:
Cheryl N. Ivey
Richmond, VAJune 9, 2005 at 3:01 pm #6703NeilMemberAdd my name also
Neil SmeatonJune 9, 2005 at 3:12 pm #6704HaroldMemberThanks for writing the letter and please add my name
William Fuller
Raleigh, NCJune 9, 2005 at 3:13 pm #6705Indiana JackMemberGood job. Please add my name as well.
John C. Schuster
South Bend, INJune 9, 2005 at 4:27 pm #6706KP2112MemberHi Everyone,
Thanks for your support for this FDA approval. I have 26 names currently. I would at least like to get it to 50 before I send it. If you know anyone that would like to be included on the list, please let me know. Maybe we could do better than 50. Also, would there be any Senators/Govenors that this may also want to be cc’d too? Some are very persistent concerning medical issues.
Again, thanks so much!
Karen -
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