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Alert Number 219

Using Revlimid Outside Clinical Trials

Date: March 4, 2007

Our recent article Revlimid to the Rescue? drew a lot of feedback from our readers.

I have heard from several CLL patients whose local oncologists are pushing them hard to start Revlimid therapy, off label and outside of clinical trials. As we pointed out in our review, just about any physician who is licensed to write a prescription can get Revlimid for his patients, the only restriction being that the patient must not be pregnant, or plan to get pregnant while on the drug.

In a couple of egregious cases, elderly patients who have had CLL for decades and had been treated successfully with minimal intervention, were being recommended a switch to Revlimid. Besides being possible overkill in these cases and tough to tolerate by the old dears, Revlimid (technical name: lenalidomide) is not presently approved for CLL and therefore insurance companies may be reluctant to cover it. While the cost of Revlimid is covered by the manufacturer when used in well designed clinical trials, outside of the clinical trial setting the price is likely to be in the region of $60,000 per patient per year. I don’t know about you, but that is a pretty steep price where I come from. You have to ask yourself, is there any chance a hefty profit motive may have a little something to do with high powered marketing effort to get Revlimid into the hands of local oncologists, ahead of FDA approval?

Scientifically, lenalidomide is a very interesting drug and understanding how it works will lead us to better therapies in CLL. Unless these guys back off a bit, there may well be a major scandal down the road with patients getting hurt because their local guy was not up to the job of diagnosing promptly and taking care of the side effects. As we discussed in our article, “tumor flare reaction” and “tumor lysis syndrome” are two potentially life threatening complications with this drug. I have a bad feeling about how this is developing. An unfortunate mishap or two might be all it takes for our regulatory agencies to overreact and block the use of the drug for legitimate, well monitored trials as well. That scenario is not in the interest of our patient community.

CLL Topics is fortunate in our long roster of world-class CLL experts who are generous with their time and often help me get things in perspective. Dr. John Byrd of Ohio State University is no stranger to our readers. Dr. Byrd responded to my query about Revlimid (lenalidomide), and his online response is quoted below, with his permission.

“Overall, I am excited about this agent because it gets us away from chemotherapy and more toward using treatments that recruit the immune system to destroy CLL cells.”

“However, the immune system is very powerful and we do not fully understand how to dose or safely give lenalidomide yet. In my opinion, lenalidomide should not be given outside of an institutional review board approved clinical trial except for rare circumstances. Clinical trials monitor safety and collect efficacy data in an organized way and will move things quicker to the point where all oncologists can administer this. If someone is in a situation where they are told there are no other options than use of lenalidomide off study, it would be wise to visit a physician that specializes in CLL for a second opinion. If lenalidomide is decided upon, it should be initiated at a CLL center that has experience with this agent and the management of tumor flare, cytokine release, and tumor lysis syndrome associated with its use. Once things have stabilized and assurance that these events have not occurred, it might be okay to transition patients back to their local doctor.”

I am reassured that OSU is being cautious about off-study use of lenalidomide. I thought I would bring you this important bit of “Best Practices”, just in case.

Be well,



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