I don’t think I’m going to enroll in that trial. I wrote to Dr. Durie, and he suggested three treatment options for me.
- Low dose Cytoxan with dex
- Doxil and dex
You might know that Revlimid hasn’t been approved by the FDA for anyone to use yet, but I’ve been told there’s an extended access program that allows some patients to receive it. I’m going to call Celgene Monday to find out more. Also, I was told it should be commercially available in September/October.
Right now, I’m taking nothing. I dread seeing my next labs! Who knows though? Maybe not much will have happened.
I recently (4 August) asked the IMF about Revlimid release date. Here is the reply (slighly edited to remove personal notes):
The whole issue of the FDA is a complicated one and I sure haven’t figured out the answer. I think there is a little of the “damned if you, damned if you don’t.” They were roundly taken to task for approving drugs like Vioxx “too early” and there have been many other drugs that were pushed through quickly and then people were unhappy with the long term side effects that were discovered post-marketing. In fact, I worry that some patients (and their lawyers) are going to go after Novartis for the ONJ-bisphosphonate problems that are now beginning to appear.
I do think that a lot of the problem is that Celgene didn’t get their data in to the FDA until fairly recently. The FDA has “fast tracked” Revlimid which means that it’ll have to be acted on within 6 months of the submission. I know that Millennium was able to get Velcade approved in record time.
I’m sorry if it appears I’m ducking the question, but to tell you the truth, I just don’t know the answer or how to solve the problem.
Thanks for writing.