Swissmedic approves REVLIMID for treatment of myelodysplastic syndromes

Nov 21 2011

Celgene International Sàrl, a subsidiary of Celgene Corporation, (NASDAQ: CELG) today announced that REVLIMID (lenalidomide) has been granted approval by the Swiss agency for Therapeutic Products (Swissmedic) for use in patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality with or without additional cytogenic abnormalities.

Myelodysplastic syndromes (MDS) are a group of hematologic malignancies that affect approximately 300,000 people worldwide. Myelodysplastic syndromes occur when bone marrow precursors of blood cells display abnormal morphological and cytogenetic features, preventing them from maturing into normally functioning peripheral blood cells. With time, most of the cells accumulate in their immature or "blast" stage and eventually the bone marrow may be filled with blasts suppressing normal cell development. Patients with MDS often develop severe anemia and require frequent blood transfusions. In most cases, the disease worsens and the patient develops cytopenias due to progressive bone marrow failure. In about one third of patients with MDS, the disease transforms into acute myeloid leukemia (AML) - usually within months to a few years.

The Marketing Authorization Application (MAA) for REVLIMID was based on the safety and efficacy results of a large, randomized, international phase III study of REVLIMID (MDS-004) and the previous phase II study (MDS-003) in patients with low-or intermediate-1 risk MDS with a deletion-5q cytogenic abnormality.