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Safety Concerns Halt Celgene Leukemia Drug Trial

Bone marrow with chronic lymphocytic leukemia

Bone marrow with chronic lymphocytic leukemia (National Library of Medicine)

The biopharmaceutical company Celgene in Summitt, New Jersey is stopping a late-stage clinical trial of its cancer drug lenalidomide to treat chronic lymphocytic leukemia due to the higher death rate of patients taking the drug. Lenalidomide is a small-molecule compound that regulates the immune system and marketed by Celgene under the brand name Revlimid.

The trial was a late-stage study of lenalidomide with patients age 65 and older having untreated chronic lymphocytic leukemia, enrolling 450 participants at 153 locations in 26 countries. In the trial, lenalidomide was tested against chlorambucil, a current drug for chronic lymphocytic leukemia, marketed by GlaxoSmithKline as Leukeran. Participants in the trial had other serious conditions, including diabetes, congestive heart failure, and kidney impairment that made them unfit for more aggressive chemo-immunotherapies.

Celgene reported 34 deaths among the 210 patients in the trial taking lenalidomide, compared to 18 deaths for the 211 patients taking the chlorambucil. While the causes of the deaths in either group have not been disclosed, FDA on 12 July placed a clinical hold on the trial, an order issued to Celgene to suspend the study.

Chronic lymphocytic leukemia is cancer of lymphocytes, a type of white blood cells found in the bone marrow and other parts of the body. It is the second most common form of leukemia, occurring almost always in older adults. The disease occurs when blood stem cells generate too many abnormal lymphocytes, particularly B-cell lymphocytes that make antibodies to fight infection.

Lenalidomide is an established compound made by Celgene that affects the functioning of the immune system and reduces the growth of new blood vessels on which tumors need to survive. The drug is approved by the FDA for other blood-related cancers including multiple myeloma, myelodysplastic syndrome, and most recently mantle cell lymphoma. Lenalidomide is an analogue of thalidomide that causes severe birth defects.

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Hat tip: FirstWord Pharma

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