FDA Advisory Committee rejects omburtamab application to treat CNS/leptomeningeal metastasis from neuroblastoma.- Y-mAbs Therapeutics, Inc,.
Y-mAbs Therapeutics, Inc. announced the outcome of the meeting of the FDA Oncologic Drugs Advisory Committee (“ODAC”), which reviewed investigational 131I-omburtamab (“omburtamab”) for the treatment of CNS/leptomeningeal metastasis from neuroblastoma. The committee voted 16 to 0 that the Company had not provided sufficient evidence to conclude that omburtamab improves overall survival.
The ODAC reviewed data from omburtamab’s clinical development program with a focus on study 03-133 (a pivotal phase 1 study) and study 101 (a pivotal phase II study) as well as the historical control group..
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