FDA Approves New Dosing Regimen for Merck’s Keytruda

The FDA granted accelerated approval to Merck’s Keytruda (pembrolizumab) at a dosing regimen of 400mg every six weeks for all previously approved adult indications.

The new dosage will now be available in addition to the current dosing regimen of 200 mg every three weeks.

Continued approval for the six-week regimen will depend on confirmatory trials to verify its clinical benefit, the agency said.