Revlimid is used to treat patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality.
Patients with MDS develop severe anemia and require frequent blood transfusions, company claims.
The marketing authorization application (MAA) for Revlimid was based on the safety and efficacy results of an international, randomized phase III study and the previous phase II study (MDS-003) in patients with low-or intermediate-1 risk MDS with a deletion-5q cytogenic abnormality.