FDA Panel Votes Sufficient Evidence Available to Support ...
FDA’s ODAC voted 14-6, finding sufficient evidence for eflornithine's EFS benefit in reducing relapse risk in pediatric high-risk neuroblastoma patients. Supported by Study 3b and ANBL0032 trial data, eflornithine showed improved EFS and overall survival, despite concerns over non-randomized trial limitations and safety warnings.
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FDA’s Oncologic Drug Advisory Committee voted 14-6, supporting eflornithine (DFMO) for reducing relapse risk in pediatric high-risk neuroblastoma patients in remission. The decision, based on Study 3b with external control data from ANBL0032, marks a potential precedent. DFMO, targeting ornithine decarboxylase, showed 85% event-free survival vs. 70% in controls, with manageable risks.
FDA’s ODAC voted 14-6, finding sufficient evidence for eflornithine's EFS benefit in reducing relapse risk in pediatric high-risk neuroblastoma patients. Supported by Study 3b and ANBL0032 trial data, eflornithine showed improved EFS and overall survival, despite concerns over non-randomized trial limitations and safety warnings.
An FDA advisory committee voted 14-6 to recommend eflornithine (DFMO) for high-risk pediatric neuroblastoma in remission, based on evidence suggesting improved 2-year event-free survival. Concerns were raised about data interpretation and the feasibility of randomized trials, but the benefits were deemed to outweigh risks.