Celgene Stops Late-Stage Trial of Revlimid® Due to High Mortality Rates
According to a recent report, Celgene has announced that it will stop a late-stage trial of its blood cancer drug, Revlimid®, after observing more deaths in elderly leukemia patients taking the drug as compared to those patients using an alternative treatment. The trial sought to test Revlimid® in formerly untreated, elderly patients with B-cell chronic lymphocytic leukemia. Ultimately, 34 out of the 210 study participants treated with Revlimid® died, compared to 18 deaths in the 211 participants receiving a chemotherapy drug. Based on these results, the FDA placed the Revlimid® late-stage trial on a clinical hold on July 12, 2013.
Revlimid® is Celgene’s flagship blood cancer drug, with 2012 sales totaling nearly $3.8 billion. However, following Celgene’s decision to discontinue the study last Thursday, Celgene shares have declined approximately 2.7 percent on the Nasdaq. Celgene has not yet identified a specific reason for the unbalanced results, but has determined that “secondary primary malignancies,” or additional cancer occurrences, were not a factor.
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