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Merck & Co.’s Keytruda Approved by FDA for Additional Recommended Dose
The approval was based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety.
Merck & Co., known as MSD outside the United States and Canada, announced on April 28, 2020 that FDA has approved an additional dosage of 400 mg every six weeks for Keytruda (pembrolizumab), Merck’s anti-programmed cell death (PD)-1 therapy, for all adult indications, including monotherapy and combination therapy.
According to a company press release, the approval was based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety. The recommended dosage will be implemented with the current dose of 200 mg every three weeks.
“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 the press release. “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.”