Celgene has completed a “rolling” submission in the USA for Revlimid (lenalidomide), a candidate treatment for the series of blood cancers known as myelodysplastic syndromes.
Revlimid is the first of Celgene’s immunomodulatory drug products to reach this stage of development, and if approved will join a crop of new treatments for MDS, including Cell Therapeutics’ Trisenox (arsenic trioxide) and Pharmion’s Vidaza (azacitidine). Also under regulatory review for MDS is MGI Pharma and SuperGen’s Dacogen (decitabine), which was filed in the US last year.
MDS, which has a number of characteristics similar to acute leukaemia, affects around 300,000 people worldwide. The most common symptom is severe anaemia, which can require the patient receive multiple blood transfusions. Revlimid has orphan drug status for this indication in both the US and European Union.
Revlimid is also in development for multiple myeloma – achieving promising results in Phase III trials reported last month [[08/03/05e]] – and various solid tumour cancers. The drug was also in development for malignant melanoma, but Celgene was forced to halt a Phase III trial in this indication last year after it became clear that it would not show efficacy.