Celgene Stops Leukemia Clinical Trial After Deaths From Drug Lenalidomide

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Positive late-stage clinical trial results are pushing ABRAXANE through priority review with the FDA for advanced pancreatic cancer treatment.

Celgene released a statement today that it will stop a clinical trial for REVLIMID (lenalidomide) in a large 450-patient late-stage Phase III ORIGIN trial. Early statistical analysis showed a disproportionate number of deaths in the group treated with the medication compared to another group treated with the drug chlorambucil.

The drug was approved in 2006 in the U.S. for the treatment of multiple myeloma and costs over $160,000 a year. Lenalidomide is a derivative molecule of thalidomide, a drug known to cause birth defects. The U.S. Food and Drug Administration placed the ORIGIN clinical trial on hold on July 12 and discontinued treatment in patients involved with the study.

The drug was being investigated for chronic lymphocytic leukemia in elderly patients over the age of 65 and suffering from other health issues, which prevented them from being treated with other medications that were more aggressive forms of chemotherapy. These other health issues included diabetes, congestive heart failure, kidney impairment, and elevated bilirubin numbers.

Out of the 210 patients who were receiving the medication in question, 34 died during the drug trial, while out of the 211 patients being treated with the other standard of care drug, chlorambucil, only 18 deaths were reported.

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