What Is Ipilimumab?

Keytruda is the first approved drug to block a cellular pathway called PD-1, which limits the body's immune system to attack melanoma cells.

Keytruda

September 4, 2014 U.S. Food and Drug Administration

Keytruda's efficacy was determined in 173 clinical trial participants with advanced melanoma who had progressed after previous treatment. All participants were treated with Keytruda, either at the recommended dose of 2 mg / kg or at the higher dose of 10 mg / kg. Among half of the participants who received Keytruda at the recommended dose of 2 mg / kg, about 24% had their tumors shrink. The effect lasts at least 1.4 to 8.5 months and continues to exceed this time in most patients. Similar percentages of patients at the 10 mg / kg dose had their tumors shrink.
Keytruda's safety was determined in 411 participants with advanced melanoma in this trial population. The most common side effects of Keytruda are fatigue, cough, nausea, itchy skin, rash, decreased appetite, constipation, joint pain and diarrhea. Keytruda also has the potential for severe immune-mediated side effects. In 411 participants with advanced melanoma, severe immune-mediated side effects involving healthy organs, including the lungs, colon, hormone-producing glands, and liver, occurred infrequently. ^[1]