Actinium Additional Leukemia Trials Required; Seeks Partner

 

• FDA determined that the Phase 3 SIERRA trial is not adequate to support a BLA filing for Iomab-B despite its statistically significant primary endpoint
  
  
• Additional head-to-head randomized clinical trial demonstrating overall survival benefit with Iomab-B is required by FDA to support a BLA filing
  
  
• Actinium to request a meeting with the FDA to further discuss specifics of additional trial
  
  
• Actinium will seek strategic partner for Iomab-B in the U.S. following completion of FDA interactions and focus development efforts on Actimab-A, Iomab-ACT and preclinical programs

https://www.prnewswire.com/news-releases/actinium-provides-regulatory-update-on-planned-bla-filing-and-future-plans-for-iomab-b-in-the-us-302213955.html