NEW YORK (AP) - Celgene Corp. said Monday it withdrew an application from
European authorities to approve its drug Revlimid to treat a cancer affecting
blood and bone marrow.
The company said it is pulling the application, for transfusion-dependent
anemia patients with myelodysplastic syndromes, because a European Medicines
Agency panel determined that data from a single mid-stage study does not
demonstrate that the benefits of the drug outweigh the risks. The committee
recommended against approval.
Celgene, however, said it plans to continue to seek approval for the
indication in Europe.
Revlimid is approved for this use in the United States, Canada and
Argentina.
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