Neuroblastoma Drug Development: Potential Surrogate Endpoint Gets US FDA Panel Backing
Advisory committee supports further research on end-of-induction response as an early interim clinical endpoint for drugs in treatment of high-risk neuroblastoma. FDA has approved two drugs for this rare disease in children, who have a 40-50% chance of long-term survival.
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In advisory committee briefing documents, the US FDA said control data was not comparable to the single-arm trial and the benefits of the monoclonal antibody were unclear.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.