FDA's AdComm Gives Thumbs Down To Pediatric Cancer Therapy

Vandana Singh
1 min read
0
In this article:

  • FDA's Oncologic Drugs Advisory Committee (ODAC) raised concerns regarding the efficacy of Y-mAbs Therapeutics Inc's (NASDAQ: 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.

See more from Benzinga

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Advertisement

Recommended Stories