Data presented at this year's American Society of Hematology meeting for myelodysplastic syndrome highlight the complexities both of the disease and of measuring treatment responses. While many companies presented positive data, initial Phase II Revlimid data from Celgene Corp. were the hardest to interpret, as the compound showed a significant benefit in a specific set of lower-risk MDS patients, but also possible treatment-related deaths.
CELG plans to seek regulatory approval in first quarter of 2005 based on the data and does not plan to present any additional data before then, leaving investors and physicians with unanswered questions about how to interpret the data.
Revlimid lenalidomide is a thalidomide analog that CELG has developed to be more potent and less teratogenic than thalidomide. The company markets Thalomid thalidomide to treat moderate to severe erythema nodosum leprosum (ENL) in leprosy but gets most of its sales from off-label use for multiple myeloma (MM).
CELG also presented Phase