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news.For treatment of patients with multiple myeloma who have received at least one prior therapy
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Celgene has filed a New Drug Application (NDA) with the Japanese Ministry of Health, Labour and Welfare (MHLW) for Revlimid (lenalidomide) in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Joseph Melillo, General Manager of Celgene, said: “The filing of an NDA in Japan for multiple myeloma represents an important step towards achieving our goal of delivering Revlimid to patients in need in one of the world’s largest oncology populations.”
The filing with the MHLW is based upon the safety and efficacy results of two randomised pivotal Phase III special protocol assessment trials: North American Trial MM-009 and International Trial MM-010 evaluating Revlimid plus dexamethasone in multiple myeloma patients who have received at least one prior therapy.