The new indication approval is for Revlimid (lenalidomide), in combination with dexamethasone, as a treatment for patients with multiple myeloma who have received at least one prior therapy. News of the approval sent Celgene shares up by around 3%.
Multiple myeloma is the second most common blood cancer in the US, affecting approximately 50,000 people. About 14,600 new cases of multiple myeloma are diagnosed each year and about 12,000 Americans are expected to die of multiple myeloma in 2006.
Revlimid is also approved for use in the treatment of patients with transfusion-dependent anemia due to low-or- intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Revlimid will be available in 5mg, 10mg, 15mg, and 25mg capsules.