Thursday March 7, 7:01 am Eastern Time
Press Release
SOURCE: Celgene Corporation
Celgene Clinical and Regulatory Update
THALOMID(R) Multiple Myeloma sNDA Strategy Revised THALOMID(R) 2002 Guidance Confirmed REVIMID(TM) Clinical Development Plan Submitted to FDA
WARREN, N.J., March 7 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG - news) announced today that, based on continuing discussions with the FDA, the Company now intends to seek marketing approval for THALOMID® (thalidomide) in early stage multiple myeloma patients. In addition to the data from the four trials that have already been prepared for submission, this supplementary new drug application (sNDA) will require an additional clinical trial before submitting the filing to the agency. The existing analyzed data will not be submitted until the completion of the additional trial. This process is expected to take approximately 24 months.
``Though the inclusion of an additional trial will delay our filing, the eventual expansion of the THALOMID label to include early stage multiple myeloma treatment could have exceptional longer-term value. It remains our objective to receive regulatory approval for THALOMID for both hematological and solid tumor cancers,'' said Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. ``Importantly, we do not believe that this revised strategy will have any impact on 2002 commercial results,'' added Dr. Barer.
``Should the additional trial produce persuasive data, THALOMID would be the first drug to receive approval for early stage multiple myeloma in thirty years,'' said Jerome B. Zeldis, M.D., Ph.D., Chief Medical Officer of Celgene Corporation. |
