FDA Approves Additional Dose for Pembrolizumab


The additional dosage is approved across all adult indications, including monotherapy and combination therapy, according to Merck.

Officials with the FDA have approved an additional recommended dosage of 400 mg every 6 weeks for pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy. The additional dosage is approved across all adult indications, including monotherapy and combination therapy, according to Merck.

Pembrolizumab is indicated by FDA approval as a therapy for multiple types of cancer. It works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

Continued approval for the new 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 3 weeks, according to Merck.

“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, in a prepared statement. “Today’s approval of an every 6-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 pembrolizumab, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation, according to Merck. Based on the severity of the adverse reaction, pembrolizumab should be withheld or discontinued and corticosteroids administered if appropriate.

Pembrolizumab can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, the drug can cause fetal harm when administered to a pregnant woman.


FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications [news release]. Kenilworth, NJ; April 28, 2020: Merck website. https://www.mrknewsroom.com/news-release/oncology/fda-approves-mercks-keytruda-pembrolizumab-use-additional-recommended-dose-400 Accessed April 28, 2020.

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