Celgene International Sàrl CELG 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).
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