FDA Approves Merck’s Keytruda of 400 mg in 6 weeks for adults

FDA has approved Merck’s Keytruda, pembrolizumab, for use at an additional recommended dose of 400 mg every six weeks for all approved adult indications.

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an additional recommended dosage of 400 mg every six weeks (Q6W) for Keytruda, Merck’s anti-PD-1 therapy, across all adult indications, including monotherapy and combination therapy.

This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy and the relationship of exposure to safety. Continued approval for this dosing may be contingent upon verification and description of clinical benefit in the confirmatory trials. This new dosage option will be available in addition to the current dose of 200 mg every three weeks (Q3W).

“The important social distancing measures for COVID-19 have created a number of challenges for people with cancer, including keeping to planned treatment schedules,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “Today’s approval of an every six-week dosing schedule for Keytruda gives doctors an option to reduce how often patients are at the clinic for their treatment.”

Immune-mediated adverse reactions, which may be severe or fatal, can occur with Keytruda, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, Keytruda should be withheld or discontinued and corticosteroids administered if appropriate. Keytruda can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, Keytruda can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.