US WorldMeds nabs FDA approval for eflornithine in neuroblastoma

Following a broadly positive advisory committee vote in October, the US Food and Drug Administration now approved US WorldMeds, Iwilfin (eflornithine) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.

This represents the first FDA approval of a therapy intended to reduce the risk of relapse in pediatric patients with HRNB, and the company said that Iwilfin will be available to patients in the USA in the coming weeks.

"We are thrilled to announce the FDA approval of Iwilfin, which provides a new and much-needed treatment option for children with high-risk neuroblastoma," said Breck Jones, chief executive of US WorldMeds, adding: "The goal for treating these young patients is to prevent relapse, and advancing therapeutic options is critical to this mission. Iwilfin offers new hope and improved outcomes for these vulnerable children."