SUMMIT, N.J, - Sunday, July 21st 2013 [ME NewsWire]
(BUSINESS WIRE) Celgene Corporation (NASDAQ: CELG) today announced that after consultation with the U.S. Food and Drug Administration (FDA) Celgene will discontinue treatment with REVLIMID® (lenalidomide) in the open-label, phase III ORIGIN® trial, which enrolled 450 patients in over 100 sites in 26 countries. An imbalance was observed in the number of deaths in patients treated with lenalidomide versus patients treated with chlorambucil.
The FDA placed the ORIGIN study on clinical hold on July 12, 2013, with the discontinuation of lenalidomide treatment. All clinical investigators in ongoing chronic lymphocytic leukemia studies using lenalidomide will be officially advised of this action and instructed to inform their patients accordingly.
REVLIMID is not approved as a treatment for patients with chronic lymphocytic leukemia.
The ORIGIN study was designed to evaluate the efficacy and safety of lena
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