- FDA's Oncologic Drugs Advisory Committee (ODAC) raised concerns regarding the efficacy of Y-mAbs Therapeutics Inc's YMAB potential pediatric neuroblastoma treatment, omburtamab.
- The adcomm voted 16 to 0 that the company had not provided sufficient evidence to conclude that omburtamab improves overall survival.
- The FDA noted that the entire application for 131I-omburtamab is based on a small, single-arm trial from New York's Memorial Sloan Kettering (MSK) Cancer Center that found the three-year overall survival rate after CNS/LM relapse in the efficacy population of 94 patients was 54%.
- "OS should generally be evaluated in randomized trials because data from externally controlled trials may not be reliable or interpretable," FDA wrote in its briefing document.
- Related: Y-mAbs Asked To Submit Additional Granularity Of Data For Omburtamab In Nerve Tissue Cancer.
- The agency also noted that patients in the 131I-omburtamab study received multimodality treatment for CNS/LM relapse before the investigational drug "that was generally more intensive than treatment documented in the external control population," FDA said.
- There is a clear trend toward improved survival with higher treatment intensity in the external control population."
- 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 2 study), as well as the historical control group.
- Y-mAbs marketing application for omburtamab was accepted for Priority Review by the FDA, with a PDUFA target date of November 30.
- Price Action: YMAB shares traded lower by 36.62% at $5.66 in premarket on the last check Monday.
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