Trial of Blood Cancer Drug Halted Because of Increased Mortality Risk

By Kelly Young

The FDA has halted a phase III trial of lenalidomide (Revlimid) after an increased mortality risk was observed, the manufacturer announced on Thursday. The drug, a thalidomide analogue, is currently approved for multiple myeloma, mantle cell lymphoma, and transfusion-dependent anemia due myelodysplastic syndromes.

In the trial, over 400 previously untreated elderly patients with B-cell chronic lymphocytic leukemia were randomized to lenalidomide or to the chemotherapy drug chlorambucil. There were 34 deaths in the Revlimid group, versus 18 in the chemotherapy group. The manufacturer notes that most patients had multiple comorbidities, but a cause for the mortality difference has not been identified.