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FDA Eyeing Other PD-1/L1 Drugs With Clinical Hold On Keytruda Myeloma Trials

 
• By Michael Cipriano

Merck previously disclosed the clinical hold on the three trials at the beginning of July; FDA says its announcement is meant to inform patients and healthcare providers about the danger of the safety signal.

Yellow road sign with a blue sky and white clouds: clinical trial
US FDA has detailed the data that led to a clinical hold on Keytruda multiple myeloma trials

The US FDA announced it is expanding its investigation into the broader field of PD-1/PD-L1 cancer drugs more than a month after the news of a clinical hold on three of Merck & Co. Inc.'s multiple myeloma clinical trials for Keytruda (pembrolizumab).

Merck announced the hold July 5, pausing three combination trials of Keytruda with Celgene Corp.'s immunomodulatory thalidomide analogues Pomalyst (pomalidomide) or Revlimid (lenalidomide), as well as dexamethasone. The hold came as a result of an increased risk of death in the Keytruda arms of each study

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