The biopharmaceutical company, Celgene Corporation, has announced that both the European Commission and the US Food and Drug Administration (FDA) have expanded the existing indication for Revlimid in combination with dexamethasone to include its use as frontline treatment for newly diagnosed myeloma patients who are not eligible for high-dose therapy and stem cell transplantation. Revlimid in combination with dexamethasone was previously approved for myeloma patients who had received at least one previous line of treatment. The new indication is based on results from the international Phase III FIRST trial demonstrating improved overall survival and progression free survival in newly diagnosed patients receiving continuous Revlimid and dexamethasone compared to those receiving a fixed duration of melphalan, thalidomide and prednisolone.

 

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