Monday, November 12, 2001
The FDA generally frowns on clinical trials that combine two unapproved therapies, which greatly complicates the analysis of results. But there are situations - such as multiple myeloma - where it otherwise would be impossible to recruit clinicians and patients, because off-label therapies are the standard of care. Thus the design of Dendreon Corp.'s Phase II trial of its Mylovenge vaccine in combination with thalidomide does not appear to have raised red flags at the agency.
DNDN (Seattle, Wash) last week began a U.S. Phase II trial of its Mylovenge dendritic cell cancer vaccine in combination with Thalomid thalidomide to treat multiple myeloma. Thalomid, which was developed by Celgene Corp. (CELG, Warren, N.J.), is marketed to treat erythema nodosum leprosum, a complication of leprosy, and is