FDA Eyeing Other PD-1/L1 Drugs With Clinical Hold On Keytruda Myeloma Trials
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.
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Highlights of the upcoming American Society of Hematology meeting include updated data for CAR-T therapies, pivotal results moving major brands into bigger markets, PD-1 inhibitors branching out into new types of hematological malignancies and dueling gene therapies in hemophilia.
Importance of randomized, controlled trials and need for a thoughtful, considered approach to development of rational combinations are highlighted by the increased mortality risk seen with pembrolizumab treatment in two halted multiple myeloma studies, FDA officials say.
Safety notice for Merck's Keytruda in multiple myeloma had some notable elements – from what comes next to who delivered the message.