Swissmedic approves REVLIMID for treatment of myelodysplastic syndromes

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.


 Celgene International Sàrl


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Innovative blood test boosts accuracy of lung cancer screening