The Food and Drug Administration approved Keytruda to treat patients with recurrent or metastatic cutaneous squamous cell carcinoma that cannot be treated with surgery or radiation.
The Food and Drug Administration on Wednesday approved Keytruda (pembrolizumab) to treat patients with recurrent or metastatic cutaneous squamous cell carcinoma that cannot be treated with surgery or radiation.
The agency based its decision on data from the open-label, multicenter KEYNOTE-629 trial, which demonstrated an objective response rate (the proportion of complete and partial responses to treatment) of 34% in patients who received Keytruda. A median duration of response was not reached in the trial.
Patients received Keytruda at 200 milligrams (mg) intravenously every three weeks until their disease either progressed, they reached unacceptable toxicity, or they reached a maximum of 24 months on therapy.
Side effects in the KEYNOTE-629 trial were comparable to those that have occurred in other clinical trials where patients also received Keytruda. The most common side effects included but were not limited to, fatigue, decreased appetite, diarrhea, rash, cough, constipation and pain.
The FDA's approval includes two different dosing options. Patients can either receive Keytruda 200 mg intravenously every three weeks or Keytruda 400 mg every six weeks.
Check back later for what you need to know about this approval.