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.
Keytruda: US FDA Reflects On Lessons Learned From Failed Myeloma Studies
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.
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Safety notice for Merck's Keytruda in multiple myeloma had some notable elements – from what comes next to who delivered the message.