FDA Approves Every Six-Week Dose of Keytruda Across All Indicated Cancer Types

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.

Keytruda is approved to treat certain cases of the following cancers: non-small cell lung, small cell lung, head and neck, bladder, gastric, esophageal, cervical, liver and kidney, as well as melanoma, Merkel cell carcinoma, classical Hodgkin lymphoma, large B-cell lymphoma and cancer that is microsatellite instability-high.

Merck noted that severe side effects can occur with Keytruda, including lung, colon or liver inflammation, hormone problems, kidney dysfunction and severe skin reactions, and stated that the drug should be withheld or discontinued, and the side effects treated with steroids, when appropriate.

“During this unprecedented time, Merck is committed to ensuring our medicines and vaccines reach our patients and customers. This includes a number of new steps to support patients in the U.S. who may have lost their jobs and insurance coverage,” the company stated in the release. Information about that response can be found at merck.com/COVID-19.