Medication Monitor

Generic Name (Trade Name—Company)
April 1, 2011


(Yervoy—Bristol-Myers Squibb)
Treatment of unresectable or metastatic melanoma


Treatment of unresectable or metastatic melanoma

Ipilimumab is a human cytotoxic T-lymphocyte antigen 4 blocking antibody whose mechanism of action is thought to be related to T-cell mediated antitumor immune responses. It is given as a 3 mg/kg 90-minute I.V. infusion once every 3 weeks for a total of four doses. The efficacy and safety were evaluated in a double-blind study involving 676 patients who had stopped responding to other agents used for the treatment of melanoma and had disease that metastasized or could not be surgically removed. Patients were randomized to one of three groups: ipilimumab alone (n = 137), ipilimumab plus the investigational vaccine gp100 (n = 403), or gp100 alone (n = 136). Those who received combination therapy or ipilimumab alone had a median overall survival of 10 months compared with 6 months for patients given gp100 alone. The drug was approved with a Risk Evaluation and Mitigation Strategy because of the risk of severe and fatal immune-mediated reactions.