RevlimidTreatment for Myelodysplastic Syndrome
FDA and Celgene Revlimid Briefing Documents for Advisory Committee Meeting Available Online
WASHINGTON, September 13, 2005 -- Celgene Corporation announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the ODAC meeting scheduled to review the Revlimid (lenalidomide) New Drug Application (NDA) seeking approval for Revlimid for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
The ODAC meeting is scheduled from 8:00 a.m. EDT to 12:30 p.m. EDT on Wednesday, September 14, 2005. The NDA for Revlimid is under FDA priority review with a PDUFA date of October 7, 2005.
Source: Celgene Corporation
Posted: September 2005
- Revlimid PDUFA Date Extended Three Months By FDA - October 3, 2005
- FDA Oncologic Drugs Advisory Committee Recommends Revlimid for Full Approval - September 14, 2005
- FDA Grants Priority Review for Revlimid NDA for Treatment of Low- and Intermediate- Risk MDS With Deletion 5q Chromosomal Abnormality - June 21, 2005
- Revlimid (lenalidomide) New Drug Application Accepted for Review by FDA - June 7, 2005
- Revlimid New Drug Application Submitted to FDA for Review - April 8, 2005