Merck announced that FDA has approved an expanded indication for Keytruda (pembrolizumab) to include the first-line treatment of patients with unresectable or metastatic melanoma. Keytruda is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Indication, dosage, and administration: Keutruda is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma.

Adverse events: The most commonly reported adverse reactions were fatigue, diarrhea, rash, and nausea. Severe and life-threatening infusion-related reactions have been reported in 3 (0.1%) of 2,117 patients. Monitor patients for signs and symptoms of infusion related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For Grade 3 or 4 reactions, stop infusion and permanently discontinue Keytruda.

Citation: FDA approves expanded indication for Merck’s Keytruda (pembrolizumab) for the treatment of patients with advanced melanoma. [news release]. Kenilworth, NJ: Merck; December 18, 2015. http://www.mercknewsroom.com/news-release/prescription-medicine-news/fda-approves-expanded-indication-mercks-keytruda-pembrolizum. Accessed December 22, 2015.