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Merck's Keytruda (pembrolizumab) Receives the US FDA's Approval for Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Indications

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Merck's Keytruda (pembrolizumab) Receives the US FDA's Approval for Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Indications

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  • The US FDA has approved Keytruda’s additional recommended dosage of 400 mg (q6w) across all adult indications- including monothx. and combination therapy. The new dosage option will be available in addition to the current dose of Keytruda (200 mg- q3w)
  • The indication is approved under accelerated approval based on PK data- the relationship of exposure to efficacy and the relationship of exposure to safety. The approval for Keytruda (400mg- q6w) provides doctors an option to reduce how often patients are at the clinic for their treatment
  • Keytruda is a mAb targeting PD-1 and its ligands- PD-L1 and PD-L2- thereby activating T lymphocytes- affecting both tumor cells and healthy cells- currently being evaluated in 1200+ trials across multiple cancer indications

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Ref: Merck | Image: Merck 

 


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