Celgene Corporation has received an approval from the US Food and Drug Administration for Revlimid (lenalidomide) which is indicated for the treatment of patients with transfusion-dependent anaemia due to low or intermediate risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
"The clinical data from a phase II trial of 148 patients demonstrated that Revlimid can reduce or even eliminate the need for transfusions in many patients with del 5q MDS," said Dr. Alan List, professor of oncology and medicine, and chief Division of Haematological Malignancies at H. Lee Moffitt Cancer Centre, Tampa, Florida, and the study's lead investigator.
According to a Celgene release, the safety profile for Revlimid has shown that neutropenia or thrombocytopenia was the most common adverse event (AE) and that patients may require a dose adjustment. Other observed and common AE's include diarrhoea, pruritis, rash, fatigue, constipation, nausea, nasopharyngitis, arthralgia, pyrexia, back pain, peripheral edema, cough, dizziness, headache, muscle cramp, dyspnoea, and pharyngitis.
"Being able to use an oral therapy such as Revlimid to treat del 5q MDS could reduce or even eliminate the need for red blood cell transfusions in MDS patients," said Dr. John Bennett, professor of oncology in medicine, pathology, and laboratory medicine, University of Rochester.
The initial shipments of Revlimid will be distributed in early 2006 Revlimid is a member of a proprietary group of novel IMiDs, immunomodulatory drugs.
Myelodysplastic syndromes (MDS) are a group of haematological malignancies that affect approximately 300,000 people worldwide. Chromosomal (cytogenetic) abnormalities are detected in more than half of patients with myelodysplastic syndrome (MDS), and involve a deletion in all or part of one or more specific chromosomes.
Celgene Corporation is a global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.