Celgene confirmed that the Japanese regulatory authorities have sanctioned Revlimid® as a combination therapy with dexamethasone for the treatment of relapsed or refractory multiple myeloma (RRMM) in patients who have received at least one prior standard therapy.
The drug will be available in Japan exclusively through Celgene’s RevMate™ distribution program, which has also been cleared by the Japan’s Ministry of Health, Labour and Welfare.
Celgene reported net sales of Revlimid were $1.71 billion during calendar year 2009, up 28.8% on 2008 figures. The drug has now been approved in some 50 countries including those in North America and Europe as a combination therapy with dexamethasone for the same RRMM indication. In Australia and New Zealand the Revlimid-dexamethasone treatment is approved for patients with multiple myeloma whose disease has progressed after one prior therapy.
Revlimid is also approved in North America, several Latin American countries, Malaysia, and Israel for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Regulatory submissions for this indication are currently under review in several other countries including Japan.
The drug is also undergoing Phase II/III trials either as a monotherapy or in combination with other drugs for the treatment of a range of hematological malignancies including MDS, chronic lymphocytic leukaemia, and non-Hodgkin lymphoma as well as for solid tumors.