title: Ipilimumab: a novel treatment for metastatic melanoma.
abstract: OBJECTIVE
  To review the mechanism of action, pharmacokinetics, efficacy, safety, drug interactions, dosing, and economic considerations of ipilimumab.
  
  
  METHODS
  A literature search using MEDLINE (1966-November 2010) was performed using the terms ipilimumab, metastatic melanoma, MDX-010, and MDX-101. Additional data were obtained from meeting abstracts, bibliographies, and media releases.
  
  
  METHODS
  English-language articles identified from the data sources were reviewed. Selected studies evaluated the pharmacology, pharmacokinetics, efficacy, and safety of ipilimumab for the treatment of metastatic melanoma.
  
  
  RESULTS
  The incidence of melanoma in the US is increasing faster than any other type of cancer in men and more than any other type of cancer, except lung cancer, in women. For patients with metastatic melanoma, systemic therapies are limited by low response rates, short durations of response, and a 5-year survival rate <10%. Ipilimumab, a novel CTLA-4 inhibitor, is under investigation for the treatment of metastatic melanoma. Results of a randomized, controlled Phase 3 trial showed a first-ever overall survival benefit for patients with previously treated metastatic melanoma who received ipilimumab compared with the controls. The majority of adverse events reported with ipilimumab administration are considered to be low-grade immune-related events involving the skin and intestine and can be managed medically. Nonetheless, 10-17% of patients have immune-related adverse events of grade 3 or higher severity, with 2-3% of these events resulting in death.
  
  
  CONCLUSIONS
  Ipilimumab is a novel CTLA-4 inhibitor that has been evaluated for the treatment of metastatic melanoma. On March 25, 2011, the Food and Drug Administration approved ipilimumab, making it the first agent indicated for unresectable or metastatic melanoma in more than a decade.
authors.affiliation: Department of Clinical and Administrative Sciences, School of Pharmacy, College of Notre Dame of Maryland, Baltimore, MD, USA.
authors.forename: Morgan E
authors.initials: ME
authors.lastname: Culver
authors.forename: Mandy L
authors.initials: ML
authors.lastname: Gatesman
authors.forename: Erin E
authors.initials: EE
authors.lastname: Mancl
authors.forename: Denise K
authors.initials: DK
authors.lastname: Lowe
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D000074324:Ipilimumab; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary; D009362:Neoplasm Metastasis; D016032:Randomized Controlled Trials as Topic; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000556:secondary; D014481:United States
chemical_list: D000911:Antibodies, Monoclonal; D000074324:Ipilimumab