Merck’s Keytruda Receives FDA Approval for New Every-Six-Weeks Dosing Schedule

On the afternoon of April 28 (local time), Merck & Co. announced that the U.S. Food and Drug Administration (FDA) had approved a new dosing regimen for Keytruda (K drug) across all adult indications, including both monotherapy and combination therapy, namely 400 mg administered every six weeks. Based on pharmacokinetic data and exposure–response relationships, the FDA granted accelerated approval for this application.

Reports on the Administration Schedule of Keytruda:

On April 23 local time, Merck & Co. announced that it had resubmitted supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) to update the dosing frequency of the anti-PD-1 therapy KEYTRUDA. The currently approved regimen is 200 mg every three weeks; the new submission proposes a 400 mg dose administered via intravenous infusion over more than 30 minutes every six weeks. The sBLAs cover all adult indications for KEYTRUDA, including both monotherapy and combination therapy.

KEYTRUDA is an anti-PD-1 therapy that works by enhancing the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes that may affect both tumor cells and healthy cells.

Roy Baynes, Vice President of Merck Research Laboratories, Global Head of Clinical Development, and Chief Medical Officer, stated: “During the COVID-19 pandemic, the oncology community rapidly adapted cancer care practices to minimize exposure and ensure that cancer patients were affected as little as possible. Therefore, we developed a six-week dosing regimen for KEYTRUDA. We appreciate the FDA’s guidance during the resubmission process and look forward to continuing our close collaboration with the FDA.”

References:

1.FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications

2.Reduce Exposure! MSD Files for New Dosing Schedule for Keytruda

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