FDAnews Drug Daily Bulletin

FDA Places Clinical Hold on Three Keytruda Studies

July 10, 2017

The FDA has placed clinical holds on three of Merck’s combination studies evaluating its Keytruda immunotherapy (pembrolizumab) in multiple myeloma.

The decision comes after a review by a data monitoring committee that found more deaths were observed in the Keytruda arms of two Phase III studies, which led to a pause in new patient enrollment announced June 12.

According to a statement from Merck, the FDA has determined that the data available at the present time indicate that the risks of Keytruda plus pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma.

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