Celgene Announces New Drug Application Filing for REVLIMID in Japan
Celgene International Sàrl announced it 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.
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. Both studies were published in the New England Journal of Medicine in November 2007. Phase I clinical results with Japanese patients, including those from MM-017, confirm similar efficacy and further support the filing.
REVLIMID was granted orphan drug status in February 2008 by the MHLW in Japan for two indications - the treatment of anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality with or without other cytogenic abnormalities, and in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy.
REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 50 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.
REVLIMID® is also approved in the United States, Canada and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorisation Applications are currently being evaluated in a number of other countries.
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