European approval for expanded use of Celgene's Revlimid

20 February 2015

US biotech firm Celgene’s (Nasdaq; CELG) European subsidiary has received approval from the European Commission for Revlimid (lenalidomide) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

The Revlimid Marketing Authorisation has been updated to include this new indication in multiple myeloma, building on the already approved indication of Revlimid in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

Earlier this week, Celgene announced that the US Food and Drug Administration had expanded the existing indication for Revlimid in combination with dexamethasone to include patients newly diagnosed with multiple myeloma (The Pharma Letter February 18).

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