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news.Celgene International Sarl has announced that, following discussions with the European Medicines Agency and the EMEA's Committee for Medicinal Products for Human use, it has withdrawn its marketing authorization application for Lenalidomide.
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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 The marketing authorization application (MAA) is being withdrawn because the CHMP considers that the currently available data, obtained from a single-arm Phase II study, do not allow it to conclude on a positive benefit-risk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.