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Neuroblastoma Drug Development: Potential Surrogate Endpoint Gets US FDA Panel Backing

 
• By Brenda Sandburg

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.

Neuroblastoma
FDA advisory committee favors further research on potential surrogate endpoint for high-risk neuroblastoma • Source: Shutterstock

Given the lengthy time it takes to develop a drug for high-risk neuroblastoma, researchers are considering use of a surrogate marker for survival. A US Food and Drug Administration advisory panel agreed that end-of-induction response looks promising and that further research should be conducted to validate its use as an interim clinical endpoint.

The pediatric oncology subcommittee of FDA’s Oncologic Drugs Advisory Committee discussed the use of end-of-induction response in clinical trials for...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.