Participating Clinical Centers
Revlimid® (lenolidomide) approved by the FDA for patients with a subgroup of myelodysplastic syndromes (MDS)
Wednesday, December 28th, 2005
Revlimid® was approved by the United States Food and Drug Administration on December 27, 2005 for the treatment of low-or-intermediate risk MDS associated with deletion of 5q, a chromosomal (cytogenetic) abnormality, with or without other cytogenetic abnormalities.
Revlimid® is expected to be available for distribution in early 2006. Since Revlimid® is chemically similar to Thalidomid® (thalidomide), it may cause severe birth defects. To ensure the safety of patients the FDA has required Celgene Corporation to market Revlimid® with a Black Box warning, and under a risk management program (a special, restricted distribution program) called RevAssist (www.revlimid.com or call 888.4CELGENE).
More information on Revlimid and the RevAssist program:
FDA Revlimid (Lenalidomide) Information page
AAMDS Revlimid (Lenalidomide) Information Page
| Back to the main news index |
