The Food and Drug Administration (FDA) has approved a higher recommended dose of the immunotherapy Keytruda (pembrolizumab), taken less often, for adult patients across all cancer types in which the drug is used. The new dose of 400 milligrams (mg) every six weeks is approved for patients who take the drug by itself as well as those who take it in combination with other medications.
The new dosage option will be available in addition to 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,” Dr. Roy Baynes, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said in a press release. “Today’s approval of an every-six-weeks dosing schedule for Keytruda gives doctors an option to reduce how often patients are at the clinic for their treatment.”
The FDA gave the green light to the new dose under accelerated approval, basing its decision on data about the way the body processes Keytruda, as well as the relationship between exposure to the drug and both efficacy and safety. To keep the approval in place, the FDA may require that these results be verified in confirmatory trials.
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