Revlimid still not approved drug

[Sandy L]

Hi Sophie,

I hear your frustration. Please be strong. Can you get Vidaza?

[Chiparoo]

Hi All,

I was told by my oncologist that Revlimid was going to patients that required regular blood transfusions. Also, to be on this drug, your WBC could not be dangerously low, especially if the platlet count is also low. He said that one of the side effects of the drug is that it intially brings these counts lower. Therefore, he put me on Vidaza just this past Monday. I’m not sure if I’ll get a chance to experience Revlimid, but for those who do, best of luck!

[Neil]

See the following site for info on Revlimid.
Some interesting data.
http://multiplemyeloma.org/treatments/3.08.02.html

The research indicates patients taking 15mg twice a day find their platelets and neutrophils decrease more than those taking 30mg once a day.
Wonder what the decrease is if a patient were to start on say 5mg per day and work their way up to 30mg over time.
Patients who found their platelet and neutrophil counts went down at the start had them increase over time.
Lots to be learned about how the drug responds with different people.
The drug is designed to kill cancer cells in myloma patients. Wonder if it kills abnormal platelets and neuts, leaving the normal cells to function, thus the reduction incounts?

[Laural]

I don’t know how this will effect the approval process for Revlimid, but this was in the news Thursday. Seems there are always a few more hoops to jump through . . .

9/28/2005 11:15:12 AM – Reuters Health
NEW YORK (Reuters) – A clinical trial of Celgene Corp.’s experimental cancer drug, Revlimid (lenalidomide), has been suspended because of concerns about blood clots, the Wall Street Journal reported on Wednesday.
The suspension comes as the company was awaiting notice from the Food and Drug Administration (FDA) next week on approval of the drug, the newspaper said.
It quoted the principal investigator in the study, S.V. Rajkumar, MD, an oncologist at the Mayo Clinic, as saying he could not comment on how many patients experienced blood clots. But he told the Journal he expected the trial would resume shortly.
The trial of 250 patients is examining Revlimid’s effectiveness, in combination with a steroid, in patients with multiple myeloma.
Celgene declined to comment on the report, the newspaper said.
The Journal cited 2 other people familiar with the study as saying it was suspended when a higher incidence of deep-vein thrombosis was seen in participants.
Trial organizers were concerned that patients were not uniformly taking aspirin, which had been recommended to them. The trial was suspended until the rules were rewritten to mandate the use of aspirin, those close to the trial told the newspaper.
They expect the trial, funded by the National Cancer Institute, to resume in a few weeks.
The suspension of the trial comes at a critical time for Warren, NJ-based Celgene, which is hoping for approval next week of Revlimid for transfusion-dependent anemia in a subset of patients with myelodysplastic syndrome.
The problem with blood clots presents a potential dilemma for the FDA, the Journal said. Even though the company is applying for approval of the drug in myelodysplastic syndrome, doctors expect that once approved, the treatment will be used much more widely in combination with a steroid in patients with multiple myeloma, as in Rajkumar’s trial.
An FDA spokeswoman declined comment, but noted that the agency generally only weighed the risks and benefits of a drug in the disease and patient group for which it was being considered for approval.

[NK]

Hello Laural,

As I could see from your Signature you have tried Revlimid. I am planning to attend into one of oncoimng studies of this Drug in Europe and looking for someone who had been treated with Revlimid before. Please share your experience with me, as it can be very helpful for me.

Rgds,
NK

[Laural]

I have secondary MDS after initial treatment for Acute Lymphocytic Leukemia in 1986. I used Revlimid through a Phase II trial. It helped me to become transfusion independent. I was unable to continue on the drug after a few months as it dropped my white counts, but I have continued to be transfusion independent and my blast cells have stayed below 3% for almost a year now. I had very few side effects while taking the drug besides the white count plummet. Typically for me, once a med can get my red cells going once again, my own body seems to be able to pick up and keep things going on its own for awhile. This is not typical for most people with MDS from what I have seen. I hope you can get into a trial and have favorable results. Good luck.
Laura

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