Ipilimumab
FDA Approves Ipilimumab for the Treatment of Unresectable or Metastatic Melanoma: A Review of Its Benefits and Risks
On March 25, 2011, the US Food and Drug Administration (FDA) approved ipilimumab for the treatment of unresectable or metastatic melanoma. Due to potentially severe or even fatal safety issues, the FDA approved this agent with a Risk Evaluation and Mitigation Strategy (REMS) to ensure the benefits of the agent outweigh the risks.This REMS includes a Dear Healthcare Provider Letter alerting clinicians to these safety issues. See: Dear Healthcare Provider Letter