Blood Cancer Is Real Prize
Celgene is betting on a quick FDA approval of Revlimid in low-risk MDS patients as the fastest way to get the drug into the hands of doctors and, of course, to begin generating revenue from the drug.
Patients diagnosed with a low-risk form of MDS represent a small commercial market opportunity. For Celgene, however, the real prize is the use of Revlimid as a treatment for multiple myeloma, a blood cancer. Many people believe that Celgene has been rushing ahead with a Revlimid filing for low-risk MDS to get the drug approved in 2005 so it can then be used off-label by doctors to treat multiple myeloma, which represents a much larger and more lucrative commercial market. Of course, Celgene won't acknowledge this because it is not allowed to promote a drug off-label.
The company is conducting pivotal phase III studies of Revlimid in multiple myeloma, with data expected next year. If positive, Celgene says it would file with the FDA for this indication in late 2005, which means the drug would not be approved until 2006.It's not uncommon for patients to die while participating in clinical trials, including patients who die for reasons unrelated to the drug being studied. The specific causes of the deaths in the Revlimid study are not yet entirely clear and won't be until Celgene makes public data from the study. But the deaths are concerning, in any case, because the patients in this study are all diagnosed with a low-grade form of MDS in which parts of the human chromosome 5 are missing. MDS patients with so-called 5q minus deletion have a disease that progresses slowly and generally does not represent a near-term risk of death.