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Celgene Corp's Oral Anti-Cancer Therapy REVLIMID (lenalidomide) Now Indicated as Treatment for Patients with Rare Form of Blood Disease


Monday, 17 Jun 2013 01:30am EDT 

Celgene Corp announced it was notified that the European Commission (EC) has amended the marketing authorisation for REVLIMID. This decision means that REVLIMID is now approved to treat patients with transfusion-dependent anaemia due to low or intermediate-1 risk myelodysplastic syndromes (MDS) associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. MDS is a type of cancer where the production of blood cells and platelets by the bone marrow is disrupted, which can often lead to severe anaemia, infections and bleeding. Approximately 50% of individuals with MDS will have some form of chromosome (cytogenetic) abnormality, and 30% of those are likely to have the specific del(5q) abnormality. In general, MDS del(5q) is associated with a poor prognosis - especially when other cytogenetic abnormalities are present - including the risk of progressing to acute myeloid leukemia (AML), which is often fatal. The European Commission`s decision on REVLIMID was based on the positive benefit-to-risk ratio in the indicated population, demonstrated by the results of MDS-004 and MDS-003.4,5 MDS-004 was a phase III, multi-center, randomized, double-blind, placebo-controlled clinical study. 

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29 Jul 2014