Merck Resubmits Supplemental Biologics License Applications (sBLAs) for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule
Merck & Company, Inc. (new) (MRK)
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Source: Business Wire
Additional sBLAs Filed Across All Approved Adult Indications KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the resubmission of its supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) to update the dosing frequency for KEYTRUDA, Merck’s anti-PD-1 therapy, to include a 400 mg dose infused over 30 minutes every six weeks (Q6W), in addition to the currently approved dose of 200 mg every three weeks (Q3W). sBLAs were filed across all adult indications for KEYTRUDA, including monotherapy and combination therapy. Merck has filed the resubmissions to address the Complete Response Letter issued in February 2020.“The oncology community is rapidly adapting cancer care during the COVID-19 pandemic in order to minimize exposure and keep cancer patients as safe as possible. Now more than ever, we believe it is critical to pursue a six-week dosing schedule for KEYTRUDA,” said
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