Revlimid still not approved drug

[Sandy L]

First I want to give you an update on Mike. Since Mike’s counts are dropping weekly, we went to U of M Sylvester Cancer Center and started the process for a BMT. He was typed and a kit is being sent to his sister. We are scheduled for another BMB on Friday. The last one he took on 7/22 they said the slides were damaged and could not tell them what they needed to know. (Blast count) The report we received was based on the flow cytometry . The slides were either too wet or too dry – I can’t remember.
This doctor wants Mike to start the Vidaza.

We also went to another local Hematologist. We waited two months for this appointment and of course lots happened before we got a chance to meet him. (Mike’s numbers are dropping and we got an appointment in Miami) Anyway, Last Friday we met with him. He reviewd Mike’s file and agreed to work with Dr. Fernandez (Sylvester Doctor) He gave Mike a shot of Procrit 40,000 and took lots of blood ….again. He is looking to see if he is producing too much iron, and checking the glucose level. Mike is always parched and can’t consume enough liquid to quench his thirst, and of course constantly going to urinate.

This Doctor – Dr. Melo – said that Mike should start Revlimid since it is less toxic and has a better track record with multiple chromosome abnormalties. He als said that Mike would probably be tx dep soon. Last numbers WBC 2.5 , RBC 3.55 , HMG 9.2 , Hmcrt 30.6 Platelets 29 .

When I asked him how many patients he is currently treating with Vidaza he said 1.

My story sounds like Sarah and Fran except for the age differences. What I wanted to know is why the drug which was supposed to be approved in 2/05 is still not approved. I have researched and still have not found out why it is being delayed. Did they find something that they are trying to fine tune before they put it on the market ? Can any one shed light on why a drug that they report will be approved shortly is still not approved 6 months later. The expected date according the a new report is 10/07/05.

I read everyone’s post every night and I get so much knowledge from my new found friends. Thank you all from the botom of my heart.

[Carl]

Having been (impatiently) waiting for Celegene to get the trial drug Revlimid approved, I called their Medical Affairs Division in February 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, which they did. Since that time the FDA has agreed to set a date of 10-7-05 for approval of the drug. I checked the FDA web site and they have designated orphan drug status to Revimid (aka Revilimid, or Lenalildomide)on January 29, 2004.
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.

[Terri]

Isn’t Revlamid also only being approved for those with 5q abnormalties. I was on one website last night It was on the AA/ MDS International Foundations website under drug info

On June 8, 2005 a New Drug Application (NDA) for lenalidomide was accepted by the US Food and Drug Administration (FDA) based on the success of its Phase II trial. On June 21, 2005 Lenalidomide was given priority review by the FDA for the treatment of low to intermediate risk MDS with deletion 5q chromosomal abnormality. For more information please click the following link: celgene.com

[Suzanne]

If they were after approval after phase 11 trials-I believe that is a fast track approval (without completing phase 111 trials). I know Zarnestra was submitted for fast track for treatment of older patients in place of chemo. FDA decided that they have to complete the phase 111 trials-wich are underway. My understanding is that this was sort of political because there was a drug (not a leukemia drug)recently pulled off the marketthat hit the news that had been approved without the phase 111 and FDA is under criticism for approving things too easily. that may be what is holding Revlimid up

[margota1]

I believe in traila it has an 85% rate with 5q. Lee has inv of 3q and we are just hoping he will be in the 8% that responded since nothing else has worked. In Denver the rep said the the FDA had given them a date of Oct. 7th! Good luck, Margot

[JulieMarie]

Does anyone know if the FDA does serriously approve Revlimid on 10-7-05 how long afterwards would we be able to begin taking the drug? Mom’s dr. appointment on 9-7-05 got pushed back to 9-15-05, we are planning a trip on 10-27-05 but don’t want to delay starting this new drug.

[Sandy L]

Thank you everyone for your responses. Mike was told that he had abnormalties with the 5 chromosome but not deleted. We went to the doctor again today. When he woke up he was having difficulty – no energy – could not walk the dog to the corner – so I made him stay home and go to the doctor. I thought they would give him a transfusion but they gave him another shot of Procrit 60,000 . – even though they gave him 40,000 on Friday. The doctor wants him to come in on Monday for another shot. How many shots can you get and ver what periord of time? Still scheduled for the BMB on Friday. My daughter and my two grandsons are coming for a short visit on Thurs. That will be the best medicine.

Margot1 -I never heard of traila – I will do some research but do you think that would be better than waiting for the Revlimid? Why is he ruled out because of age. Do you have an insurance issue ? I thought there were some place that took you till the age of 70.

Carl – Are you waiting for Revlimid also?

Terri – How is Bob?

JulieMarie – Good luck on you appointment tomorrow. Let us know how you make out.

Suzanne – Thank you for that information. I did not know how the system works.

[Carl]

Sandy L.,

Yes I am waiting for the Revlimid to be approved. Sooner the better as far as I am concerned.

[KP2112]

Hi Everyone,

I noticed the inquiries regarding Revlimid. As per the letter that was sent out, we did receive a response from the FDA saying that the drug was under review by and FDA panel and a decision as to whether it will be approved with be announced in early October. I hope our voices will contribute to Revlimid’s approval.

Kind Regards,
Karen P.

[Laural]

Hi all,
The following came over the internet today! Hopefully the final approval will come very shortly.

BETHESDA, Md., Sept 14 (Reuters) – A U.S. advisory panel on Wednesday voted 10-5 to recommend approval of Celgene Corp.’s Revlimid to treat anemia in patients with potentially fatal blood disorders known as myelodysplastic syndromes.

The drug is a new version of Celgene’s Thalomid or thalidomide, and aims to be safer with fewer side effects.

The Food and Drug Administration will make the final decision but usually heeds the advice of its advisory panels.

Laura

[Terri]

The following was in the Sept bulletin from the AA/MDS International Org publication

FDA Oncologic Advisory Committee to Meet 9/14/05 to Discuss Revlimid®, Public Attendees Welcome — Learn more and register to attend by visiting http://www.fda.gov/. This meeting will be held in Bethesda, Maryland. The Advisory Committee offers a telephone information line for current information during this meeting at 800-741-8138, code

[KP2112]

Hi Everybody,

I think this is great news as well!

09/14/05 – FDA Oncologic Drugs Advisory Committee Recommends REVLIMID(R) for Full Approval

Wednesday, September 14, 2005 – Celgene Corporation announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) recommended full approval of REVLIMID(R) (lenalidomide) for the treatment of transfusion-dependent patients with myelodysplastic syndromes (MDS) with 5q minus with or without additional chromosomal abnormalities. The committee based its recommendation on clinical data from an open label Phase II trial, evaluating REVLIMID(R) in MDS patients with deletion 5q chromosomal abnormality. The FDA expects to complete their review and decision by October 7, 2005. Read Celgene’s press release at http://www.celgene.com and FDA’s Briefing Document for the September 14, 2005 Oncologic Drugs Advisory Committee Meeting.

Learn about FDA’s Drug Approval Process at http://www.fda.gov. Click here to view information about Revlimid® from our Drug Information Page.

[KP2112]

Also, if anyone is interested in the status of Exjade (oral medication to reduce iron), this medication will be reviewed by the FDA’s Blood Committee on September 29, 2005 and a decision should be made by Nov. 7, 2005.

Let us keep our fingers crossed.

Kindest Regards,
Karen

[Suzanne]

This is really great! Drugs heading for approval shows the progress they are making in treating this disease even if each drug only works for selective patients. When I was diagnosed there were no approved treatments.

[**DONOTDELETE**]

Hi, I’m another one desperately waiting to get hold of Revlimid. Been 18 months so far and I’m no nearer and it’s driving me mad. There’s a study in Scotland, but I’m excluded because I have another chromosal abnormality as well as 5q. There’s two studies lined up in London but Celgene are withholding Revlimid it seems because they want the trials to be restricted to only a few patients who have the best chance of giving them good results.
Does anyone know why Celgene are refusing to allow Revlimid to be used on compassionate basis?
I am clinging to the hope that after 7th October Revlimid will become available, so will be watching this space in the hope of more news.
I feel like flying to America and marching into Celgene’s head office and shouting “hurry up for goodness sake! some of us dying out here you know..!”

[Author]

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