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Trial of Top Cancer Drug Halted Over Deaths

Filed July 18th, 2013 Laurie

Celgene Corp. had no other recourse but to stop a trial of Revlimid, the company’s top-selling drug, after more patients died using the drug than those taking a competing medication.

Thirty-four of 210 patients taking Revlimid died compared to 18 of 211 patients taking the chemotherapy drug chlorambucil. Celgene has yet to determine the reason for the imbalance and plans to move forward with clinical trials in lymphocytic leukemia. Revlimid is approved by the U.S. Food and Drug Administration (FDA) to treat multiple myeloma, and researchers were hoping to expand the drug’s use to include a type of blood cancer known as B-cell chronic lymphocytic leukemia, according to Bloomberg News.

The halted trial was in its final stage and was designed to support use of Revlimid in patients age 65 and older who suffered from other illnesses that would have prevented them from undergoing standard chemotherapy. Most of the patients involved in the trial also had multiple diseases, like diabetes, heart failure, or kidney failure, Bloomberg News reported.

The majority of those who died during the trial were quite elderly. “A majority of these patients that had died were much older, even 80 or older,” Greg Geissman, a company spokesman, told Bloomberg News in a phone interview. “These are patients who were not eligible for standard treatments. It’s a patient group in need, but elderly and frail, unfortunately.”

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