The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Revlimid (lenalidomide) as a maintenance treatment for newly diagnosed myeloma patients who have undergone high-dose therapy and stem cell transplantation (SCT). Revlimid is currently licensed for use in combination with dexamethasone for myeloma patients who have received at least one previous line of treatment and for newly diagnosed transplant-ineligible patients. The latest extension of the therapeutic indication for Revlimid is primarily based on results from the CALGB 100104 and IFM 2005-02 Phase III trials, both of which showed that patients receiving Revlimid maintenance treatment post-SCT had significantly increased progression-free survival. A final decision from the European Commission is expected within the next 60 days.


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