Orphan drug status was granted for the treatment of both anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality with or without other cytogenic abnormalities, and in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy.
Graham Burton, global regulatory affairs and pharmacovigilance for Celgene, said: “The decision by the MHLW to grant lenalidomide orphan drug status for both relapsed/refractory multiple myeloma and deletion 5q MDS represents a major step in our efforts to deliver Revlimid as a therapeutic option for patients living with these conditions worldwide as quickly as possible.”