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The U.S. Food and Drug Administration has expanded the approved use for Revlimid (lenalidomide) in combination with dexamethasone to now include patients with newly diagnosed multiple myeloma. Revlimid was previously approved for the treatment of patients with multiple myeloma who had received at least one prior therapy (2006).

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This approval for Revlimid, which is made by Celgene, is based on safety and efficacy results from randomized, open-label Phase III studies, including the FIRST trial, which evaluated continuous treatment with Revlimid in combination with dexamethasone until disease progression versus melphalan, prednisone, and thalidomide (MPT) for 18 months as the primary analysis, and a fixed duration of 18 cycles of the Revlimid combination as a secondary analysis.


Of 1,623 newly diagnosed patients who were not candidates for stem cell transplant who participated in the studies, median progression-free survival was 25.5 months for those receiving the Revlimid combination compared with 21.2 months for those receiving MPT. Median overall survival was 58.9 months for patients receiving the Revlimid combo compared with 48.5 months for patients receiving MPT, based on an interim analysis last year. Patients receiving the Revlimid combination had a 25 percent reduction in risk of death compared with patients receiving MPT.


Grade 3 or 4 events for patients receiving the Revlimid combination were neutropenia, anemia, thrombocytopenia, pneumonia, asthenia, fatigue, back pain, hypokalemia, rash, cataract, dyspnea, deep vein thrombosis, and hyperglycemia.


Revlimid was also previously approved for the treatment of patients with relapsed mantle cell lymphoma, as well as for patients with disease that has progressed after two prior therapies, one of which included bortezomib (OT 7/10/13 issue).