FDA GRANTS PRIORITY REVIEW FOR REVLIMID

The FDA has granted Celgene priority review designation for its new drug application for Revlimid with a Prescription Drug User Fee Act (PDUFA) date of Oct. 7.

Celgene is seeking approval to market Revlimid as a targeted treatment for transfusion-dependent patients with low- and intermediate-risk myelodysplastic syndromes with deletion 5q chromosomal abnormality. The company expects the application will be reviewed by the FDA's Oncology Drug Advisory Committee in September.