FDA raises efficacy concerns with Y-mAbs' potential therapy for pediatric neuroblastoma ahead of ODAC meeting
Ahead of a key meeting of the FDA’s Oncologic Drugs Advisory Committee tomorrow, the FDA is raising serious concerns regarding the efficacy of Y-mAbs Therapeutics’ potential pediatric neuroblastoma treatment.
Part of the problem for FDA is that the entire application for 131I-omburtamab is based on a small, single-arm trial from New York’s Memorial Sloan Kettering Cancer Center that found the three-year overall survival rate after CNS/LM relapse in the efficacy population of 94 patients was 54%.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.