A step towards FDA approval for Thalomid

Celgene Corporation today announced the U.S. FDA issued an approvable letter in response to the Company's sNDA for multiple myeloma. The FDA has requested revised product labeling with the specific indication of newly diagnosed multiple myeloma and updated safety information, as well as some additional patient information to finalize its review.

The THALOMID sNDA is based on results from a large Phase III randomized Eastern Cooperative Oncology Group study comparing thalidomide plus dexamethasone to dexamethasone alone in previously untreated multiple myeloma patients.

(From the Celgene Corporate web site http://www.celgene.com/