The company is seeking approval to market Revlimid as a targeted treatment for transfusion-dependent patients with low to intermediate risk of myelodysplastic syndromes (MDS) with deletion 5q chromosomal abnormality.
Priority review is granted to a pharmaceutical product that, if approved, would be a significant improvement compared to existing marketed products or approved therapies in the treatment, diagnosis, or prevention of a disease. It is the expectation of Celgene that the application will be reviewed at an Oncology Drug Advisory Committee (ODAC) meeting in September.
The application was based primarily upon the safety and efficacy results of a multi-center phase II study of low and intermediate risk MDS patients with deletion 5q chromosomal abnormality (MDS-003), and supplemented by supportive data from two additional MDS trials.
Revlimid is an IMiD immunomodulatory drug, which affects multiple intracellular biological pathways. The pipeline of IMiDs, including Revlimid, is covered by a comprehensive US and foreign issued and pending patent applications, but as yet is not approved by the FDA or any other regulatory agencies as a treatment in any indication.
Myelodysplastic syndromes are a group of hematologic malignancies, which, according to Celgene, affect approximately 300,000 people worldwide. Myelodysplastic syndromes occur when blood cells remain in an immature or “blast” stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow may be filled with blast cells suppressing normal cell development.