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Celegene-Revimid or Revlimid FDA Approval

This topic has 3 replies, 1 voice, and was last updated 17 years, 6 months ago by Carl.

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February 8, 2005 at 3:35 pm #3999

Carl
Member

Having been (impatiently) waiting for Celegene to get the trial drug Revlimid approved, I called their Medical Affairs Division yesterday to see what the progress was and when they expected the drug to be approved for public use. They told me that initial approval information went to the FDA the last quarter of 2004 and they are scheduled to send some additional information the end of March 2005. The person I spoke with said they had no idea when the drug would be approved by the FDA and available for public use.
I checked the FDA web site and they have designated orphan drug status to Revimid (aka Revilimid, or Lenalildomide)on January 29, 2004. There is no information from the FDA on approval of the drug.
Celegene said they do not dispense the drug under a compassionate basis and the only way to get it now is through a clinical trial, which are all closed at the moment. They said to check the web site for clinical trials (http://www.clinicaltrials.gov) for “CC-5033” to see if any new trials come open.
I had a very favorable red blood count response to Thalidomide but the numbness (neuropathy) in my feet and fingers caused me to stop the end of November 2004. Now I have to go back on it or try some of the other drugs that have reported more harsh side effects.

February 8, 2005 at 6:12 pm #4000

sarah
Member

Best of luck to you Carl, thanks for updates.

October 20, 2006 at 4:25 am #4001

campbell
Member

Carl… I am interested if you are on Revilmid now and the outcome….. my husband is starting it soon……… we are from central Al. but live in Fl. now. Thanks for any imput you have.

October 20, 2006 at 3:18 pm #4002

Carl
Member

campbell,

Unfortunately the Revlimid did not work for me. I tried it at different dosages for a couple of months and all it did is drive my counts down to record low levels and made me feel terrible. Celegene claims only about a 25% success rate even with those with 5q- but I was not one of the people that had a positive response. Others have had a good response and even some without the 5q- chromosome defect.

Good luck to your husband, I pray it works for him.
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