The Food and Drug Administration (FDA) has approved eflornithine to decrease the chance of relapse in adult and pediatric patients diagnosed with high-risk neuroblastoma (HRNB).
This approval marks a significant milestone as it is the first FDA-authorized treatment aimed at lowering the risk of relapse, specifically in pediatric patients with HRNB.
The FDA approved Eflornithine for High-Risk Neuroblastoma based on the results of a comparative analysis between Study 3b (NCT02395666; investigational arm) and Study ANBL0032 (clinical trial-based external control arm).
This decision acknowledged the drug’s substantial evidence in decreasing the risk of relapse among pediatric patients with HRNB who are in remission after completing multi-agent, multi-modality therapy.
Source: FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-eflornithine-adult-and-pediatric-patients-high-risk-neuroblastoma
