US biotech major Celgene Corp (Nasdaq: CELG) said yesterday (July 18) that, after consultation with the US Food and Drug Administration, it will discontinue treatment with Revlimid (lenalidomide) in the open-label, Phase III ORIGIN trial in chronic lymphocytic leukemia, 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 company noted. Celgene’s shares, which have been trading at all-time highs, fell 3.4% to $131.92 in morning trading on Thursday.
The stock moved higher earlier this month, when the company said its Phase III study (MM-020/IFM 07-01) of Revlimid in combination with dexamethasone in patients newly-diagnosed with multiple myeloma met its primary endpoint of progression-free survival (PFS), an indication for which it is not approved anywhere at this stage (The Pharma Letter July 11).
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