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.
You may also be interested in...
Keytruda, Tecentriq Face Efficacy Questions In Urothelial Cancer
Monotherapy patients with tumors that have low PD-L1 expression experienced decrease survival in two confirmatory trials; however, the immune checkpoint inhibitors’ accelerated approvals are unlikely to be affected pending final results comparing use in combination with chemotherapy to chemo alone.
Deciphering US FDA’s Keytruda Safety Announcement
Safety notice for Merck's Keytruda in multiple myeloma had some notable elements – from what comes next to who delivered the message.
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.