Lenalidomide was intended for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality. The marketing authorization application (MAA) is being withdrawn because the CHMP considers that the currently available data, obtained from a single-arm Phase II study, do not allow it to conclude on a positive benefit-risk balance.
Celgene International Sarl is continuing its clinical development program of lenalidomide with the intention to seek marketing approval in MDS.