Celgene's REVLIMID Wins Positive CHMP Opinion

Celgene International Sàrl

today announced the European Medicines Agency's (EMA): Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for REVLIMID^® for the treatment of patients with transfusion-dependent anemia 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. The CHMP, which reviews applications for all 27 member states in the European Union (EU), as well as Norway and Iceland, has recommended approval for REVLIMID in this indication. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within two to three months. If approval is granted, detailed conditions for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR). 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 anemia, infections and bleeding. Approximately 50 percent of individuals with MDS will have some form of chromosome (cytogenetic) abnormality, and 30 percent 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 – as well as an increased risk of MDS progressing to acute myeloid leukemia (AML).