FDA Approves Additional Recommended Dose of Pembrolizumab in Adults

The FDA approved an additional recommended dose of 400 mg pembrolizumab (Keytruda) every 6 weeks across all adult indications.

The FDA approved an additional recommended dose of pembrolizumab (Keytruda) across all adult indications, according to Merck, the agent’s manufacturer.

The accelerated approval is for 400 mg pembrolizumab every 6 weeks as a monotherapy or in combination with other agents, which is crucial given the current coronavirus disease 2019 (COVID-19) pandemic, according to Roy Baynes, MD, PhD.

“The important social distancing measures for COVID-19 have created a number of challenges for people with cancer, including keeping to planned treatment schedules,” Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said in a press release. “Today’s approval of an every 6-week dosing schedule for (pembrolizumab) gives doctors an option to reduce how often patients are at the clinic for their treatment.”

The approval is contingent upon verification and description of clinical benefit in the confirmatory trials. In addition to this approval, pembrolizumab was previously approved to be administered at a dose of 200 mg every 3 weeks.

Immune-related adverse events associated with pembrolizumab include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation.



Merck. FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications. Published April 28, 2019. https://www.mrknewsroom.com/news-release/oncology/fda-approves-mercks-keytruda-pembrolizumab-use-additional-recommended-dose-400. Accessed April 28, 2019.