US biotech firm Celgene (Nasdaq: CELG) has been given approval to market Revlimid (lenalidomide) in the European Union as a monotherapy for the maintenance treatment of certain adult patients with newly-diagnosed multiple myeloma.
Revlimid becomes the first and only medicine licensed in Europe to treat patients who have undergone autologous stem cell transplantation (ASCT). The decision was made on the basis of data from two Phase III studies.
The label expansion follows the announcement made two days ago that the US Food and Drug Administration (FDA) had also approved Revlimid as a maintenance therapy for certain patients with multiple myeloma.
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